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

Catalog Number 200218

Device Problem Material Disintegration (1177)

Patient Problem Insufficient Information (4580)

Event Date 11/02/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event 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 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.

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
• Type of Device: 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
• MDR Text Key: 328077569
• Report Number: 3011137372-2023-00247
• Device Sequence Number: 1
• Product Code: GDY
• UDI-Device Identifier: 04026704417681
• UDI-Public: 04026704417681
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K913302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 200218
• Device Lot Number: 22C0719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1