MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NORTHFIELD LOU MINOR PROCEDURE PACK; GENERAL SURGERY TRAY

Catalog Number CMPJ47432F

Device Problem Contamination (1120)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

After opening room a hair was found in basin after contents had been placed on table which contaminated everything.Had to flash instruments from zimmer rep set because there were no more of those sets available.Fda safety report id# (b)(4).

• Brand Name: LOU MINOR PROCEDURE PACK
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NORTHFIELD; northfield IL
• MDR Report Key: 13142193
• MDR Text Key: 283174170
• Report Number: MW5106413
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CMPJ47432F
• Device Lot Number: 21HBU146
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1