MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 36IN 2-0 S/A CP-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J472H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device ml7058, 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 in 2019 and suture was used.The thread of the suture is easy to break.There were no patient consequences reported.
Additional Manufacturer Narrative
An empty opened foil, an empty labeled winding former, a needle/suture piece and a suture piece of product were received for evaluation.During the visual inspection of sample, the swage and attachment area were noted to be as expected and marks were observed on the needle by use of the surgical instrument and the suture piece was noted used and with body fluids, the ends of the second suture piece present damaged (cut) appears to be by use of a surgical instrument.The product contains an absorbable suture and as the sample was received open, the time of exposure of sutures to the environment could not be determined and no functional test can be performed due to sample condition.As with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of the surgical instruments, such as needle holders and forceps.Per the condition of the sample received, the assignable cause of the performance breakage suture suggest an improper handling.

• Brand Name: VCL CT BRD VIO 36IN 2-0 S/A CP-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9292790
• Report Number: 2210968-2019-89700
• Device Sequence Number: 2310521
• Product Code: GAM
• UDI-Device Identifier: 10705031040250
• UDI-Public: 10705031040250
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 10/14/2019

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: 09/30/2023
• Device Catalogue Number: J472H
• Device Lot Number: ML7058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 12/06/2019
• Patient Sequence Number: 1