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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 7317 SPG VISTEC 4X4 STR 10'S; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

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COVIDIEN 7317 SPG VISTEC 4X4 STR 10'S; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE Back to Search Results
Model Number 7317
Device Problem Material Separation (1562)
Patient Problem No Patient Involvement (2645)
Event Date 03/13/2019
Event Type  malfunction  
Event Description
The customer reports the blue x-ray threads that is on the front and back is missing on one side or does not go all the way across.
 
Manufacturer Narrative
A review of the device history record (dhr) for lot no.18k076562 indicated the product was released meeting all quality standards.All dhrs are reviewed for accuracy prior to product release.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.A photograph sample was provided for evaluation.Without a physical sample, a comprehensive investigation was unable to be conducted.We are unable to identify the cause of the short radiopaque element and reach a root cause.The reported customer complaint is unable to be confirmed.A root cause could not be determined.Notifications to employees involved in the production of this product were provided to heighten awareness for this issue.This complaint will be utilized for tracking and trending purposes.
 
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Brand Name
7317 SPG VISTEC 4X4 STR 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 Key8432515
MDR Text Key139202056
Report Number1018120-2019-00342
Device Sequence Number1
Product Code GDY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 04/01/2019
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
Device Operator No Information
Device Model Number7317
Device Catalogue Number7317
Device Lot Number18K076562
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/13/2019
Initial Date FDA Received03/19/2019
Supplement Dates Manufacturer Received03/13/2019
Supplement Dates FDA Received04/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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