MAUDE Adverse Event Report: O&M HALYARD INC. QUICK CHECK STERILIZATION WRAP; WRAP, STERILIZATION

Catalog Number 34198

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/17/2020

Event Type  malfunction  

Event Description

(b)(4): wrap has multiple holes in it in a linear line with packaging intact.Defect is from manufacturer.This week, there have been trays with holes in the wrap that match this pattern of holes.

• Brand Name: QUICK CHECK STERILIZATION WRAP
• Type of Device: WRAP, STERILIZATION
• Manufacturer (Section D): O&M HALYARD INC.; 9120 lockwood blvd; mechanicsville VA 23116
• MDR Report Key: 11162944
• MDR Text Key: 226620434
• Report Number: 11162944
• Device Sequence Number: 1
• Product Code: FRG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 34198
• Device Lot Number: LR0292000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/04/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1