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

Model Number	7462
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported receiving 13 x-ray gauze inside the pack instead of 10.
Additional 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
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): COVIDIEN; 1430 marvin griffin road, po b; augusta GA 30906
• MDR Report Key: 11605517
• Report Number: 1018120-2021-00441
• Device Sequence Number: 3622053
• Product Code: GDY
• UDI-Device Identifier: 10884527017065
• UDI-Public: 10884527017065
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2021

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: No Information
• Device Model Number: 7462
• Device Catalogue Number: 7462
• Device Lot Number: 20K091662
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 07/29/2021
• Patient Sequence Number: 1