MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 0 S/A CTX; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP364H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluation summary: one detached needle and one suture piece of product code vcp364, lot mjm737 were returned for analysis.During the visual inspection of the detached needle, the swage and attachment area were noted to be as expected, but marks appears to be by use of surgical instrument could be found on the body needle.The suture piece was examined.A correct insertion mark and body fluids were observed; also, the end was cut.In addition, the force used to detach needle from the suture could not be determined.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition, it could not be determined what may have caused the reported incident.Photos of the sample were received for analysis.Upon visual inspection of the picture, a detached needle with body fluids and the strand could be observed.However, no conclusion could be reach 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.A manufacturing record evaluation was performed for the finished device mjm737 number, and no non-conformances were identified.Second device reported in mw 2210968-2019-84293.
Event or Problem Description
It was reported that a patient underwent a caesarean section procedure on (b)(6) 2019 and suture was used.The suture was detached from the needle during use.There were no adverse patient consequences.

• Brand Name: VCL+ VIO 27IN 0 S/A CTX
• 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: 8791000
• Report Number: 2210968-2019-84292
• Device Sequence Number: 1822776
• Product Code: GAM
• UDI-Device Identifier: 10705031052772
• UDI-Public: 10705031052772
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/19/2019

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: 07/31/2023
• Device Catalogue Number: VCP364H
• Device Lot Number: MJM737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 07/15/2019
• Patient Sequence Number: 1