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	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.
Event or Problem Description
The customer reported that they discovered an additional sponge within the bundle.

• 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: 9601717
• Report Number: 1018120-2020-00397
• Device Sequence Number: 2927882
• 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: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/17/2020

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: 19L008362
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 01/17/2020
• Patient Sequence Number: 1