MAUDE Adverse Event Report: COVIDIEN 4334 VISTEC SPG 4X3.5 32 PLY; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	4334
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.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 that they received a pack with 11 gauze instead of 10.

• Brand Name: 4334 VISTEC SPG 4X3.5 32 PLY
• 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: 9139961
• Report Number: 1018120-2019-00379
• Device Sequence Number: 3123694
• Product Code: GDY
• UDI-Device Identifier: 10884527016686
• UDI-Public: 10884527016686
• 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,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/01/2019

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: 4334
• Device Catalogue Number: 4334
• Device Lot Number: 19E133862
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2019
• Initial Report FDA Received Date: 10/01/2019
• Patient Sequence Number: 1