MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; GAUZE,SPONGE,4"X4",16PLY,XRAY,STRL,LF

Catalog Number	NON21430LF
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2024 during a "total parathyroidectomy" when using the product "strands of material were left behind in the patient cavity".The customer reported the strands were "manually" removed from the field and a different product was used.The customer reported there was no serious injury or follow-up care needed related to the reported incident.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer, on (b)(6) 2024 during a "total parathyroidectomy" when using the product "strands of material were left behind in the patient cavity".
Additional Manufacturer Narrative
Update h6: investigation conclusion.

• Common Device Name: GAUZE,SPONGE,4"X4",16PLY,XRAY,STRL,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes dr; northfield, IL 60093 ; 8479492650
• MDR Report Key: 18935185
• Report Number: 1417592-2024-00427
• Device Sequence Number: 12484222
• Product Code: GDY
• UDI-Device Identifier: 40080196832348
• UDI-Public: 40080196832348
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: NON21430LF
• Device Lot Number: 6052306059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown