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

Model Number	DYNJ44804F
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: LAPAROSCOPY KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 16688909
• Report Number: 16688909
• Device Sequence Number: 5930928
• Product Code: FDE
• UDI-Device Identifier: 10195327323325
• UDI-Public: 10195327323325
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/22/2023
• Report Date (Section F): 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/24/2023