MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 36IN 0 S/A V-34; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP518H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device number, and no non-conformance's were identified.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 the patient underwent an unknown procedure on (b)(6) 2019 and suture was used.The suture strand detached from the swage of needle.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 02/03/2020.Device evaluation summary photo: two pictures were received for analysis.Upon visual inspection of the pictures, the following was observed.A dispenser box of the product code vcp518h, lot # mb2946 and a detached needle, the assignable cause how this happened could not be determined, and no conclusion could be reach as the sample was not returned for analysis.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to the sample condition, the complaint could be confirmed, however the cause could not be determined.Additional information was obtained: customer confirmed the complaint sample id not available to return.

• Brand Name: VCL+ VIO 36IN 0 S/A V-34
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9510788
• Report Number: 2210968-2019-91229
• Device Sequence Number: 2217138
• Product Code: GAM
• UDI-Device Identifier: 10705031054042
• UDI-Public: 10705031054042
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 12/03/2019

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: 01/31/2023
• Device Model Number: VCP518H
• Device Catalogue Number: VCP518H
• Device Lot Number: MB2946
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 02/03/2020
• Patient Sequence Number: 1