MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; LAPAROSCOPY KIT

Model Number DYNJ35353F

Device Problems Break (1069); Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 12/08/2020

Event Type  malfunction  

Event Description

The insufflation tubing in medline pack number dynj35353f has a lure lock tip on the end of the tubing that breaks when items are attached to it and or it does not attach properly.The contents list of the medline pack no longer lists the item numbers along with each item listed in the pack contents list.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: LAPAROSCOPY KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11093601
• MDR Text Key: 224255715
• Report Number: 11093601
• Device Sequence Number: 1
• Product Code: FDE
• 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: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DYNJ35353F
• Device Catalogue Number: DYNJ35353F
• Device Lot Number: 20GMD155
• 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: 12/18/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1