inforMED
MalfunctionKDD

MEDLINE STERILE PLASTIC BASIN PACK

Received Mar 13, 2023 · Event occurred Mar 6, 2023

Report MW5115724 · MDR key 16537264

Device

Generic name

Kit, Surgical Instrument, Disposable

Model number

DYNJ63883C

Catalog number

42981-DNQ BFC CVR TBL 80X110 H

Lot number

22JDC142

Product problems

  • Device Contaminated During Manufacture or Shipping

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

DEAD BUG FOUND INSIDE THE MEDLINE STERILE PLASTIC BASIN PACK WHILE PREPARING FOR CASE IN THE OPERATING ROOM. ENTIRE KIT WAS TORN DOWN AND DISPOSED OF UPON DISCOVERY. ENTIRE SET-UP WAS DISASSEMBLED, RE-PICKED, AND REASSEMBLED. COULD HAVE CONTAMINATED THE ENTIRE SET-UP FOR CASE.