MalfunctionLRO

HALYARD CUSTOM PLASTICS PACK

Received Nov 6, 2024 · Event occurred Oct 24, 2024

Report MW5162266 · MDR key 20630368

Device

Generic name

General Surgery Tray

Manufacturer

Owens And Minor / Avid Medical, Inc. A Medical Action Ind. Company 305

Catalog number

RYPL32-02

Lot number

1624269

Patient

51 YR · Female

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

Narrative

Description of Event or Problem

SET UP FOR PLASTIC SURGEON'S PORTION OF CASE. ONCE OPENED, THERE WERE BLACK SPECKS ON SUPPLIES IN THE CUSTOM PACK. PATIENT IN OPERATING ROOM AT THAT TIME. SURGEON AWARE OF INCIDENT AT THAT TIME. CONTAMINATED PACK WAS A HALYARD PLASTICS CUSTOM PACK. THIS CONTAMINATION IS THE 4TH CONTAMINATION FOR THIS PATIENT USING HALYARD PLASTICS CUSTOM PACK. CALLED FOR NEW CUSTOM PACK. HALYARD LOT # IS 1624269. REFERENCE REPORTS: MW5162045, MW5162045-1, MW5162267, MW5162268.