MAUDE Adverse Event Report: COVIDIEN 7462 VISTEC SPG 8X4 12P T-10'S; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number 7462

Device Problem Nonstandard Device (1420)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported receiving 13 x-ray gauze inside the pack instead of 10.

Manufacturer Narrative

Investigation conclusion: the customer reported receiving a total count of 13 surgical gauze inside a 10 count pack.The product was discarded.A device history record (dhr) review was completed for the reported lot and no manufacturing related issues were identified.As part of our manufacturing process, prior to release of product, all device history records are reviewed and approved by quality.The reported product was not returned for evaluation as it was discarded; therefore, the failure of "miscount- surgical gauze" was not confirmed.A complaint trend analysis of the reported product family identified a trend requiring action.An investigation has been initiated to determine the root cause of the reported product issue.The scope of the investigation encompasses the reported lot number manufactured on 2020-10-21.This complaint will be closed and used for tracking and trending purposes.

• Brand Name: 7462 VISTEC SPG 8X4 12P T-10'S
• Type of Device: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): COVIDIEN; 1430 marvin griffin road, po b; augusta GA 30906
• MDR Report Key: 11605517
• MDR Text Key: 243832974
• Report Number: 1018120-2021-00441
• Device Sequence Number: 1
• Product Code: GDY
• UDI-Device Identifier: 10884527017065
• UDI-Public: 10884527017065
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 7462
• Device Catalogue Number: 7462
• Device Lot Number: 20K091662
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/29/2021
• Patient Sequence Number: 1