MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NORTHFIELD MEDLINE ACCU-SORB X-RAY DETECTABLE GAUZE; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Lot Number	26022120023
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024 at approximately 1300 during a uni knee a raytec became stuck in the patients knee under an instrument.When the surgeon pulled it out it shredded into two pieces.All pieces were recovered.No x-rays needed, all counts were correct.

• Brand Name: MEDLINE ACCU-SORB X-RAY DETECTABLE GAUZE
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NORTHFIELD
• MDR Report Key: 18704223
• Report Number: MW5151569
• Device Sequence Number: 8331751
• Product Code: GDY
• UDI-Device Identifier: 10080196832347
• UDI-Public: (01)10080196832347
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/07/2024

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
• Operator of Device: Health Professional
• Device Lot Number: 26022120023
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Race: White