MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 18IN 5-0 S/A P-3 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J463G
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the device bunched up/frayed.It is unknown if a similar device was used to complete the procedure.There were no adverse patient consequences reported.No additional information was available.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 08/06/2019.Device evaluation summary: thirty-four unopened samples of product code j463, lot # mmm103 were received for evaluation.The complaint sample was not received.During the visual inspection of thirteen representative sample, no defects were found on the packages.The samples were opened and contain a strand per packet.The sutures were dispensed without problems and examined along of the strand and no defects, damaged or fraying suture was observed.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to visual inspection of the samples received no performance fraying suture intra-op were observed.Representative samples returned to support investigation of 3 device issues captured in reports 2210968-2019-83739, and 2210968-2019-83741.Analysis results have been included in follow-up reports for each.

• Brand Name: VCL CT BRD VIO 18IN 5-0 S/A P-3 PRM MP
• 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: 8768665
• Report Number: 2210968-2019-83740
• Device Sequence Number: 1690002
• Product Code: GAM
• UDI-Device Identifier: 10705031040137
• UDI-Public: 10705031040137
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2019

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: 10/31/2023
• Device Catalogue Number: J463G
• Device Lot Number: MMM103
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 07/08/2019
• Supplement Report FDA Received Date: 08/06/2019
• Patient Sequence Number: 1