MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 36IN 1 S/A CTXB; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCPB977H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2020
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 a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Device return follow up.The single complaint was reported with multiple events.There are no additional details regarding the additional patient events.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that a patient underwent a gynecological procedure on an unknown date and suture was used.During the procedure, the suture popped of the needle.Another box was opened of a different lot number to finish the case.There were no adverse patient consequences.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Evaluation: an empty opened foil, an empty folder and unopened samples of product were received for analysis.The complaint sample was not received for evaluation.During the visual inspection of the samples, no defects were found on the packages.The samples were opened, and swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand with no defects, or damage observed.A functional test was performed and the pull force was 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 conditions of the samples received, no suture needle pull off was found, and the tested samples met the finished goods requirements.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Date sent to the fda: 07/17/2020.A manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.Additional information was requested, and the following was obtained: how many sutures pulled off from the needle during use in this one patient procedure? customer only stated 'several' but did not provide exactly how many.Could you please confirm if the other 3 devices that were not opened present the issue of pull off? no 3 device returning as representative samples - unopened.The single complaint was reported with multiple events.There are no additional details regarding the additional patient events.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: VCL+ UD 36IN 1 S/A CTXB
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10232404
• Report Number: 2210968-2020-05067
• Device Sequence Number: 3194260
• Product Code: GAM
• UDI-Device Identifier: 10705031056770
• UDI-Public: 10705031056770
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 06/22/2020

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: 04/30/2023
• Device Model Number: VCPB977H
• Device Catalogue Number: VCPB977H
• Device Lot Number: MEM227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 07/07/2020; 07/21/2020
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 07/17/2020; 07/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1