The Ministry of Food and Drug Safety ordered a recall of some 110,000 intravenous fluid products from two local medical suppliers following two cases in which an insect was found inside the sealed plastic bag.
The Ministry of Food and Drug Safety
Health authorities confirmed two cases of contaminated IV bags reported since Sunday. A tiny dead insect was found inside the product, while being administered to a five-month-old child at Ewha Womans University Mokdong Hospital. Parents found it and called hospital staff to disconnect the IV product from their child.
In another case, reported Tuesday, a nurse at Inha University Hospital in Incheon found a contaminated IV product and reported it to the authorities. A cockroach is suspected, officials said.
The two products are from different suppliers, Sungwon Medical and Shinchang Medical.
Health authorities, while investigating the cases, suspended business of the manufacturers and ordered a recall of the entire 40,000 products supplied by them.
Sungwon Medical, which supplied to Ewha university hospital, has a factory in the Philippines that manufacture half-finished products. The later process of assembling, packaging and labelling the products is done here.
Suspecting that the insect may have gotten inside during the manufacturing process, the ministry said it will conduct an onsite investigation at the factory in the Philippines.
Parents of the infant that received fluids from the tainted bag blamed hospital staff for negligence and a flawed hygiene management of the medical equipment.
The ministry, however, said inspections showed that there was no breach of rules on the side of the hospital.
Authorities said the investigation into the IV fluid bag from Shinchang Medical which allegedly had a roach in it was still at an early stage Wednesday.
The ministry said it will conduct a special inspection next month to strengthen the manufacturing process and hygiene management of medical products.
By Kim Da-sol (email@example.com)