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

Catalog Number	VCP518H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The review of the batch manufacturing records was conducted, and the batch met all finished goods release criteria.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 surgery on (b)(6) 2019 and the suture was used.It was reported that the suture strand detached form swage of the surgical needle.Another like device was used to complete the procedure.There were no patient consequences reported.No further information is available.
Additional Manufacturer Narrative
Date sent to the fda: 07/17/2019.
Additional Manufacturer Narrative
(b)(4).H3 device evaluation summary: photo analysis upon visual inspection of the pictures, an opened sample of product code vcp518 lot# mb2946 with body fluids at the folder could be observed.Device analysis it was received for analysis an empty opened foil, an empty labeled winding former and a needle of product code vcp518, lot mb2946.During the visual inspection of the needle, the swage and attachment area were as expected, and remnant of the suture was noted into the barrel hole and slightly marks were observed on the edge of the needle that appears to be by the use of a surgical instrument.The suture was not received for evaluation.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition the assignable of the performance pull off - suture needle, suggest an improper handling of the sample.

• 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 0151
• MDR Report Key: 8801051
• Report Number: 2210968-2019-84432
• Device Sequence Number: 3026924
• Product Code: GAM
• UDI-Device Identifier: 10705031054042
• UDI-Public: 10705031054042
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 06/21/2019

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 Catalogue Number: VCP518H
• Device Lot Number: MB2946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Initial Date Received by Manufacturer: 06/21/2019
• Supplement Date Received by Manufacturer: 06/21/2019; 08/01/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 07/17/2019; 08/27/2019
• Patient Sequence Number: 1