MAUDE Adverse Event Report: TELEFLEX MEDICAL SPG NEURO STRL XRAY STRG 1X3 200/BX; GAUZE/SPONGE, INTERNAL

Catalog Number	200102
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
Reported as "neuro sponges falling apart".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
Reported as "neuro sponges falling apart".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 13 nov 2023 states the defect was found "when customer was pre-moistening the sponges prior to use on patient".The sample was 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.Samples that were provided showed that the product was not manufactured by carwild corp.No root cause can be determinate.There is not enough information in the teleflex notification summary, such as: body place of use, solution used, time of the sponge inside the patient and samples sent were not manufactured by carwild corp." teleflex will continue to monitor and trend for reported of this nature.Other remarks: n/a.Corrected data: n/a.

• Brand Name: SPG NEURO STRL XRAY STRG 1X3 200/BX
• Common Device Name: GAUZE/SPONGE, INTERNAL
• 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: 18120159
• Report Number: 3011137372-2023-00249
• Device Sequence Number: 20718075
• Product Code: EFQ
• UDI-Device Identifier: 04026704417506
• UDI-Public: 04026704417506
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K791871
• 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): 11/06/2023

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: 200102
• Device Lot Number: 22D1297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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