MAUDE Adverse Event Report: COVIDIEN 7318 SPG VISTEC 8 X 4 STR 10'S; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	7318
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the x-ray detectable thread came out of the gauge sponge during use.
Additional Manufacturer Narrative
Additional information a device history record (dhr) review was completed for the reported lot number.There were no manufacturing related issues related to the complaint.Inspections are performed based on a statistical sampling both physically and visually.Specifically, operators are required to inspect samples at the beginning, middle and end of lots.These checks are noted on the dhr.A photo was submitted for evaluation with the complaint.From the photo it can be seen that the element has separated from the sponge.The photo shows the coloring of the radiopaque element to be a solid blue.Radiopaque elements that are produced at this manufacturing site are comprised of white and blue polyvinyl chloride, and the element will be speckled white and blue throughout.From the picture we cannot confirm the complaint.A sample was sent in; however, the sample was only the lid of a tray package.Sponges were not submitted for review, so an analysis cannot be done.Operators are being briefed on the customer¿s complaint.The root cause could not be determined.Without a physical sample to evaluate, a corrective and preventative action (capa) cannot be completed.This complaint will be used for trending purposes.

• Brand Name: 7318 SPG VISTEC 8 X 4 STR 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: 9467984
• Report Number: 1018120-2019-00392
• Device Sequence Number: 14229044
• Product Code: GDY
• UDI-Device Identifier: 00884527017006
• UDI-Public: 00884527017006
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2020

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: 7318
• Device Catalogue Number: 7318
• Device Lot Number: 19E195D62
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 01/27/2020
• Patient Sequence Number: 1