MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 12X18IN 4-0 NON NDL; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP109G
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
(b)(4).A manufacturing record evaluation was performed for the finished device lot number kdz395, and no non-conformances related to the reported complaint condition were identified.It was reported packaging integrity.Two pictures were received for evaluation.Upon visual inspection of pictures, the following was observed: an empty opened foil packet of product code (b)(4), lot # kdz395 with several wrinkles and holes could be observed; however, no conclusion could be reach as the sample was not returned for analysis.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Events submitted via 2210968-2020-04049 and 2210968-2020-04054.
Event or Problem Description
It was reported that the patient underwent an unknown surgery in 2020 and the suture was used.Upon checking the packaging for suture, multiple holes found in the packaging.It was also reported that there was an issue with the integrity of the packaging.The holes were extremely small and not visible unless put up against light.There was no patient involvement.

• Brand Name: VCL+ UD 12X18IN 4-0 NON NDL
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10077533
• Report Number: 2210968-2020-04054
• Device Sequence Number: 3923978
• Product Code: GAM
• UDI-Device Identifier: 10705031051478
• UDI-Public: 10705031051478
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/11/2020

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: VCP109G
• Device Catalogue Number: VCP109G
• Device Lot Number: KDZ395
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 05/20/2020
• Patient Sequence Number: 1