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

Catalog Number	200104
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during use on a patient, the device "has been shedding during procedures leaving cotton fibers in the surgical field.This product is used in nasal and airway cases".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The customer's information for use, established that the "neurosponges are intended to be used in the protection of tissue during surgical procedures; tissues include the brain and other central nervous system tissues by providing moisture and absorbing fluids".The complaint indicates, "this product is used in nasal and airway cases." there was limited information reported regarding how the neurological sponge was used in the nasal, such as, how long it had been left inside the nasal.A device history record review was performed and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that during use on a patient, the device "has been shedding during procedures leaving cotton fibers in the surgical field.This product is used in nasal and airway cases".No patient harm or injury.The patient status is reported as "fine".

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17767706
• Report Number: 3011137372-2023-00220
• Device Sequence Number: 14993919
• Product Code: EFQ
• UDI-Device Identifier: 04026704417520
• UDI-Public: 04026704417520
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/29/2023

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: 200104
• Device Lot Number: 21K3164
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 10/16/2023
• 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