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

Model Number	J385H
Medical Device Problem Codes	Break (1069); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) investigation summary: it was reported breakage suture.One photo was provided for analysis.Upon visual inspection of the picture, one open foil, one empty labeled winding former and a suture piece of product code j385, lot kdk370 could be observed.However; no conclusion could be reached 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 photo, the reported complaint was confirmed.A manufacturing record evaluation was performed for the finished device lot kdk370, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2020; and a suture was used.During the procedure, the suture broke.Another like device was used to complete the procedure.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 05/04/2020.Additional h3 investigation summary: it was received for analysis an opened sample of product code j385h, lot kdk370.During the visual inspection of sample, the suture has begun with the process of degradation and the strand was broken in multiples pieces, this is the cause that breakage suture.The product code j385h contains absorbable sutures and as the sample was received open, the time of exposure of suture to the environment could not be determined and no functional test can be performed due to sample condition.Also, the foil was examined and showed multiples wrinkles and holes in the foil package due to excessive manipulation.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 cause of performance breakage suture, was caused by suture degradation; due to the improper handling of package.

• Brand Name: VCL CT BRD VIO 18IN 5-0 S/A C-3
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9981301
• Report Number: 2210968-2020-03277
• Device Sequence Number: 4597865
• Product Code: GAM
• UDI-Device Identifier: 10705031039476
• UDI-Public: 10705031039476
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K022269
• 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): 03/30/2020

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: 03/31/2021
• Device Model Number: J385H
• Device Catalogue Number: J385H
• Device Lot Number: KDK370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2020
• Initial Date Received by Manufacturer: 03/30/2020
• Supplement Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 04/21/2020
• Supplement Report FDA Received Date: 05/04/2020
• Patient Sequence Number: 1