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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. SILK BLK 18IN 4-0 S/A P-3 PRM MP; SUTURE, NONABSORBABLE, SILK
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ETHICON INC. SILK BLK 18IN 4-0 S/A P-3 PRM MP; SUTURE, NONABSORBABLE, SILK Back to Search Results
Model Number 641G
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/27/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).To date, no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent.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 an unknown procedure on (b)(6) 2020, and a suture was used.During the procedure prior to insertion to secure umbilical catheter, the needle was observed to be broken when it was removed from the package.There were no adverse patient consequences reported.Additional information was requested.
 
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Brand Name
SILK BLK 18IN 4-0 S/A P-3 PRM MP
Common Device Name
SUTURE, NONABSORBABLE, SILK
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
MDR Report Key10626767
Report Number2210968-2020-07618
Device Sequence Number3620862
Product Code GAP
UDI-Device Identifier10705031007390
UDI-Public10705031007390
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K946173
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/23/2020
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 Health Professional
Device Model Number641G
Device Catalogue Number641G
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/23/2020
Initial Report FDA Received Date10/05/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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