MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. C-SECTION PACK; CESAREAN SECTION TRAY

Model Number	DYNJ04620S
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was not in operating room (or) at time of discovery.Staff was setting up (opening) for a surgery.When opening lap sponges, staff found a bug imbedded in a lap sponge.Lap sponge was removed, place in plastic bag.

• Brand Name: C-SECTION PACK
• Common Device Name: CESAREAN SECTION TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 19258485
• Report Number: 19258485
• Device Sequence Number: 16796408
• Product Code: OHM
• UDI-Device Identifier: 10195327135850
• UDI-Public: (01)10195327135850
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/08/2024
• Report Date (Section F): 01/08/2024

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: DYNJ04620S
• Device Catalogue Number: DYNJ04620S
• Device Lot Number: 23HIMH659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/07/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2024
• 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: 01/08/2024