MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 18IN 3-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP497H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device pd2736, and no non-conformances were identified.Attempts are being made to retrieve the device.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 surgeon was having issues with suture breaking at the swage during surgery.The procedure was completed with another device.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Date sent to the fda: 01/14/2020.H3 device evaluation summary: two unopened samples of product code vcp497, lot ph2144 were received for analysis.The complaint sample was not returned for evaluation.During the visual inspection of the samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strands and no defects were observed.A functional test was performed and the pull force were above the minimum 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 samples, no performance pull off suture needle was found, and the tested samples met the finished goods requirements.A manufacturing record evaluation was performed for the finished device ph2144, and no non-conformances were identified.Expiration date: 06/30/2024.Date of mfg.: 07/09/2019.A manufacturing record evaluation was performed for the finished device pd2736, and no non-conformances were identified.Expiration date: 03/31/2024.Date of mfg.: 04/26/2019.Representative samples returned to support investigation of device issues captured in reports 2210968-2019-90721, 2210968-2019-90722 and 2210968-2019-90723.Analysis results have been included in follow up reports for each.

• Brand Name: VCL+ UD 18IN 3-0 S/A PS-2 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9457512
• Report Number: 2210968-2019-90721
• Device Sequence Number: 11531229
• Product Code: GAM
• UDI-Device Identifier: 10705031053823
• UDI-Public: 10705031053823
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K032420
• 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,Followup
• Report Date (Section B): 11/22/2019

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: 03/31/2024
• Device Catalogue Number: VCP497H
• Device Lot Number: PD2736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 01/14/2020
• Patient Sequence Number: 1