inforMED
MalfunctionNNZ

MEDLINE PENROSE DRAIN

Received Aug 17, 2022 · Event occurred Aug 8, 2022

Report MW5111567 · MDR key 15250417

Device

Generic name

System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile

Model number

DYND50428

Lot number

59221122514

Product problems

  • Break
  • Material Split, Cut or Torn

Patient

40 YR · Female

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

DRAIN CUT TO 16 CM FOR USE AS RETRACTOR FOR HIATAL HERNIA REPAIR. DRAIN TORN AND 2CM PIECE BROKE AWAY. DISCOVERED DURING SURGERY AND REMOVED. DRAIN PIECES ALL PLACED TOGETHER AND FULL DRAIN ACCOUNTED FOR. MANAGEMENT NOTIFIED. DEFECTIVE PRODUCT FORM COMPLETE. DRAIN PLACED IN BIOHAZARD BAG FOR FURTHER EXAMINATION AND GIVEN TO MANAGEMENT. FDA SAFETY REPORT ID# (B)(4).