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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN SPNG,GAUZE,4 IN X 4 IN,16 PLY,; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
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COVIDIEN SPNG,GAUZE,4 IN X 4 IN,16 PLY,; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE Back to Search Results
Model Number 7148
Medical Device Problem Code Material Fragmentation (1261)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Samples were not received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the defect and root cause analysis.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa tracking and trending purposes.
 
Event or Problem Description
The customer reports that strands/strings have been falling off of the gauze.
 
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Brand Name
SPNG,GAUZE,4 IN X 4 IN,16 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 Key8832183
Report Number1018120-2019-00371
Device Sequence Number10840677
Product Code GDY
UDI-Device Identifier10884527016969
UDI-Public10884527016969
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/26/2019
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 Number7148
Device Catalogue Number7148
Device Lot Number18B170662
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/17/2018
Initial Report FDA Received Date07/26/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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