MAUDE Adverse Event Report: ETHICON INC. VCL CT UD 27IN 3-0 S/A CT-2; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J232H
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Investigation summary: it was reported performance fraying suture intra-op and performance surface related defect - suture.An empty opened box, an empty opened foil and twenty-one unopened samples of product code j232, lot pa2194 were returned for analysis.During the visual inspection of thirteen unopened samples, no defects were found on the packages.The samples were opened and the swage and attachment area needles were observed to be as expected.The sutures were dispensed without problems and test tactile was performed on sutures and no defects, damage or fraying suture along of the strand were noted.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the representative samples, no performance fraying suture intra-op or performance surface related defect - suture was found.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the suture kept bunching up and fraying.Another like device was used to complete the procedure.There were no patient consequences reported.No additional information was provided.

• Brand Name: VCL CT UD 27IN 3-0 S/A CT-2
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8666542
• Report Number: 2210968-2019-82276
• Device Sequence Number: 2233059
• Product Code: GAM
• UDI-Device Identifier: 10705031038288
• UDI-Public: 10705031038288
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/06/2019

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: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: J232H
• Device Lot Number: PA2194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 06/04/2019
• Patient Sequence Number: 1