MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 18IN 4-0 S/A PC-5 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP823H
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pc-(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.An empty opened foil, an empty winding former, a paper lid, a dispensed suture in several pieces and a detached needle during the visual inspection of the sample, the swage and attachment area were as expected; however, the suture pieces have begun with the process of disintegration; this is the cause of the needle was detached from the strand.Also, the foil was examined for visual inspection and showed multiples wrinkles and holes outside to inside was noted in cavity on the back- foil package due to excessive manipulation and this condition contributed to degradation of the suture.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 is a suture degradation; due to the improper handling of package.
Event or Problem Description
During an evaluation on 10/23/2018 for a suture and suture packaging, holes in the packaging were noted.There were no adverse patient consequences reported.No additional information was available.

• Brand Name: VCL+ UD 18IN 4-0 S/A PC-5 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: 8014075
• Report Number: 2210968-2018-76807
• Device Sequence Number: 11201456
• Product Code: GAM
• UDI-Device Identifier: 10705031055674
• UDI-Public: 10705031055674
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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
• Report Date (Section B): 10/23/2018

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: 06/30/2022
• Device Catalogue Number: VCP823H
• Device Lot Number: LH6699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 10/29/2018
• Patient Sequence Number: 1