MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. GEN CV LAPAROSCOPY PACK-LF; LAPAROSCOPY KIT

Model Number DYNJ44804F

Device Problem Contamination (1120)

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

Event Date 03/16/2023

Event Type  malfunction  

Event Description

A foreign body was found on the towel in the pack.Neither the pack nor the foreign body was saved.Did not present any adverse outcomes for the patient.

• Brand Name: GEN CV LAPAROSCOPY PACK-LF
• Type of Device: LAPAROSCOPY KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 16688909
• MDR Text Key: 312771805
• Report Number: 16688909
• Device Sequence Number: 1
• Product Code: FDE
• UDI-Device Identifier: 10195327323325
• UDI-Public: 10195327323325
• 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: 03/24/2023,03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYNJ44804F
• Device Catalogue Number: DYNJ44804F
• Device Lot Number: 23ABR303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/24/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1