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 Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the sponges are coming apart from the string.The string is not holding the sponges together when removing them from the patient.No patient harm or injury.The patient status is reported as "fine".See associated mdr 3011137372-2023-00237.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4) complaint verification testing could not be performed as no sample was returned for analysis.The customer's information for use (ifu) references the string in only for location purposes, not for sponge removal.A dhr could not be performed as a lot number was not reported.A root cause was unable to be determined.Teleflex will continue to monitor and trend for reported of this nature.Other remarks: n/a corrected data: n/a.
Event or Problem Description
It was reported that the sponges are coming apart from the string.The string is not holding the sponges together when removing them from the patient.No patient harm or injury.The patient status is reported as "fine".See associated mdr 3011137372-2023-00237.

• 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: 18041683
• Report Number: 3011137372-2023-00235
• Device Sequence Number: 18206446
• Product Code: EFQ
• UDI-Device Identifier: 04026704417520
• UDI-Public: 04026704417520
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 10/12/2023

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: N/A
• 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: 10/12/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 01/25/2024
• 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