MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 36IN 3-0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP344H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that the patient underwent an unknown procedure in 2020 and the suture was used.It was reported that the suture's needle was already broken while the package was opened.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 3/26/2020.A manufacturing record evaluation was performed for the finished device lot number: pb2133, and no non-conformances related to the reported complaint condition were identified.Additional h3 investigation summary: it was reported performance breakage needle.An empty opened foil, a paper lid, a dispensed needle/suture piece and an empty howi tray of product code: vcp344, lot#: pb2133 were received for evaluation.During the visual inspection of the sample, the swage and attachment area were noted to be as expected.No needle breakage or marks could be observed.The suture end was noted detached due to stress applied to strand; however, no body fluids were present.Also, the needle was tested by resistance test to needle and met the requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the sample received, no performance breakage needle were found.

• Brand Name: VCL+ VIO 36IN 3-0 S/A CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9619673
• Report Number: 2210968-2020-00614
• Device Sequence Number: 2927825
• Product Code: GAM
• UDI-Device Identifier: 10705031052536
• UDI-Public: 10705031052536
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2020

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 Expiration Date: 01/31/2024
• Device Model Number: VCP344H
• Device Catalogue Number: VCP344H
• Device Lot Number: PB2133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Received by Manufacturer: 01/03/2020
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 01/22/2020
• Supplement Report FDA Received Date: 03/26/2020
• Patient Sequence Number: 1