MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE LAP CHOLE STERILE PACK; LAPAROSCOPY KIT

Catalog Number CMPJ11452

Device Problem Contamination (1120)

Patient Problem Insufficient Information (4580)

Event Date 04/13/2021

Event Type  malfunction  

Event Description

Sterile pack contaminated with hair in sterile field.Fda safety report id# (b)(4).

• Brand Name: MEDLINE LAP CHOLE STERILE PACK
• Type of Device: LAPAROSCOPY KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC. ; northfield IL
• MDR Report Key: 11677882
• MDR Text Key: 246018032
• Report Number: MW5100810
• Device Sequence Number: 1
• Product Code: FDE
• Reporter Country Code: US
• 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: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: CMPJ11452
• Device Lot Number: 20EBS438
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1