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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 2 X 18"(45CM) 7-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC
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ETHICON INC. PROLENE SUTURE 2 X 18"(45CM) 7-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC Back to Search Results
Catalog Number EPM8746
Medical Device Problem Code Component Incompatible (1108)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
 
Event or Problem Description
It was reported that a patient underwent a coronary artery bypass graft procedure on an unknown date and suture was used.During the procedure, the doctor removed the needle from the packet and the needle was a larger diameter than what the doctor expected.The doctor continued to use the same needle to complete the procedure.There were no adverse patient consequences reported.No additional information was provided.
 
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Brand Name
PROLENE SUTURE 2 X 18"(45CM) 7-0 BLU
Common Device Name
SUTURE, NONABSORBABLE, SYNTHETIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
MDR Report Key7565787
Report Number2210968-2018-73272
Device Sequence Number1979777
Product Code GAW
UDI-Device Identifier10705031203686
UDI-Public10705031203686
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K133356
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 05/08/2018
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 Health Professional
Device Catalogue NumberEPM8746
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 05/08/2018
Initial Report FDA Received Date06/04/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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