MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 18IN 5-0 S/A P-2 PRM; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP503G
Medical Device Problem Code	Material Separation (1562)
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).Attempts are being 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 the patient underwent an unknown surgery on an unknown date and suture was used.The needle pulled off from the suture during surgery.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot mem810, and no non-conformances were identified.It was received for analysis an empty opened foil, a labeled winding former with a partially dispensed suture and a detached needle of product code vcp503, lot mem810.During the visual inspection of the needle, the swage and attachment area were noted to be as expected and remnant of the suture inside of the barrel hole could be observed.In addition, slightly marks at the edge of the needle that appears to be by the use of a surgical instrument were found.The suture was examined the end of the suture is severely damaged appears to be by the use of a surgical instrument.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 of the performance - pull off suture needle, suggest an improper handling of the sample.

• Brand Name: VCL+ UD 18IN 5-0 S/A P-2 PRM
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9267575
• Report Number: 2210968-2019-89389
• Device Sequence Number: 14014230
• Product Code: GAM
• UDI-Device Identifier: 10705031053908
• UDI-Public: 10705031053908
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Report Date (Section B): 10/07/2019

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: 04/30/2023
• Device Catalogue Number: VCP503G
• Device Lot Number: MEM810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 12/24/2019
• Patient Sequence Number: 1