MAUDE Adverse Event Report: TELEFLEX MEDICAL SPG RSEBD STRL XRAY FOAM 1/4" 200/BX; GAUZE/SPONGE, INTERNAL, X-RAY

Catalog Number	200218
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The report states, "our or team reported that these sponges shred in the surgical field".At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.
Event or Problem Description
The report states, "our or team reported that these sponges shred in the surgical field".At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.
Additional Manufacturer Narrative
(b)(4).Additional information received on 15 nov 2023 states that there was no patient harm or injury.The current status of the patient is unknown.The sample was not returned to the manufacturer (carwild corporation) for investigation.Carwild reports: "the investigation was based on the review of dhr, manufacturing procedures, historical complaint and training records, and no findings were found.No sample was provided therefore a proper investigation cannot be performed.A picture of the product packaging was sent after investigation that yielded no impact on investigation.No corrective action was conducted." teleflex will continue to monitor and trend for reported of this nature.Other remarks: n/a.Corrected data: n/a.

• Brand Name: SPG RSEBD STRL XRAY FOAM 1/4" 200/BX
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18133735
• Report Number: 3011137372-2023-00247
• Device Sequence Number: 6349166
• Product Code: GDY
• UDI-Device Identifier: 04026704417681
• UDI-Public: 04026704417681
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K913302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 200218
• Device Lot Number: 22C0719
• 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: 11/07/2023
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown