MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE SURGERY PACK; GENERAL SURGERY TRAY

Catalog Number CMPJ09401B

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Insufficient Information (4580)

Event Date 12/17/2020

Event Type  malfunction  

Event Description

Insect found in general laparoscopy pack during set up.Manufacturer response for surgery pack, medline (per site reporter).They will initiate a quality investigation and reimburse for the product.

• Brand Name: MEDLINE SURGERY PACK
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11146871
• MDR Text Key: 226047982
• Report Number: 11146871
• Device Sequence Number: 1
• Product Code: LRO
• 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: 01/06/2021,01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: CMPJ09401B
• Device Lot Number: 20FBN469
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/06/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1