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

Model Number DYNJ35353F

Device Problems Break (1069); Disconnection (1171); Product Quality Problem (1506); Material Too Rigid or Stiff (1544); Mechanics Altered (2984); Material Too Soft/Flexible (4007)

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

Event Date 01/13/2023

Event Type  malfunction  

Event Description

The insufflation tubing within the lap chole pack product #dynj35353f is too rigid compared to the original product placed in the pack.The lure lock connection doesn't rotate as the original product did, causing the connected equipment to become disconnected during use and the plastic that the lure lock is made of is brittle and will break during use.This insufflation tubing is a substitute for the original product within the lap chole pack and is listed as: tbg insufflation cpc white.Lap chole pack lot number is 22imf646.This is an ongoing issue that has been reported to medline.

• Brand Name: LAP CHOLE PACK
• Type of Device: LAPAROSCOPY KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl; mundelein IL 60060
• MDR Report Key: 16223363
• MDR Text Key: 307891057
• Report Number: 16223363
• 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: 01/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNJ35353F
• Device Catalogue Number: DYNJ35353F
• Device Lot Number: 22IMF646
• 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: 01/16/2023
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1