MAUDE Adverse Event Report: TELEFLEX MEDICAL SPG NEURO STRL XRAY STRG 1/2X3" 200/BX; GAUZE/SPONGE, INTERNAL

Model Number	IPN004227
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.
Event or Problem Description
Cottonoids falling apart in patient's nose.
Event or Problem Description
Cottonoids falling apart in patient's nose.
Additional Manufacturer Narrative
(b)(4).An investigation was performed by reviewing the dhr.The review confirmed that there were no changes to in the raw materials and/or manufacturing processes.The incoming raw material inspection records indicated there was no abnormalities.To further investigate, it was observed that the in the customer's complaint statement that the product was being used in the patient nose.The neurosponge are intended to be used in the protection of tissues during surgical procedures; tissues including the brain and central nervous system by providing moisture and absorbing fluids.Based on the dhr, incoming inspection and customer statement the root cause of the reported condition could not be reliably determined.Carwild will continue monitor for root cause determination.

• Brand Name: SPG NEURO STRL XRAY STRG 1/2X3" 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 14685754
• Report Number: 3011137372-2022-00102
• Device Sequence Number: 17351756
• Product Code: EFQ
• UDI-Device Identifier: 04026704417520
• UDI-Public: 04026704417520
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2022

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 Expiration Date: 08/04/2025
• Device Model Number: IPN004227
• Device Catalogue Number: 200104
• Device Lot Number: 20G1882
• 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: 06/03/2022
• Supplement Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 08/02/2022
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown