MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 8X18IN 2-0 S/A CT-2 CR; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP726D
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported prior to unknown procedure on (b)(6) 2019 suture was used.It was noted that the information was inconsistent between inside and outside package.The labeling on the outer sterile package is labeled as 26mm, but inside paper lid is labeled as 27mm.No reported patient consequences.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Additional device evaluation summary: one empty opened foil, a paper lid and a winding former with eight needle-suture combination of product code vcp726, lot kg2750 were returned for analysis.During the visual inspection of the sample, mismatched between the length of the needle printed at the foil and the one printed at the paper lid could be observed; since, the graphics indicates that the needle length on the foil package is 26 mm while the needle length on the paper lid indicate 27mm.The final quality release criteria was met before this lot was released for distribution.Per the condition of the sample received, the assignable cause of packaging - labeling identification is incorrect print information.Photo evaluation: inconsistent labeling between inside and outside package issues were noted.Picture of the sample was received for analysis.Upon visual inspection of the pictures, mismatched between the length of the needle printed at the foil and the one printed at the paper lid could observed.The final quality release criteria was met before this lot was released for distribution.

• Brand Name: VCL+ VIO 8X18IN 2-0 S/A CT-2 CR
• 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: 8813055
• Report Number: 2210968-2019-84544
• Device Sequence Number: 14067760
• Product Code: GAM
• UDI-Device Identifier: 10705031055117
• UDI-Public: 10705031055117
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 06/25/2019

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: 05/31/2021
• Device Catalogue Number: VCP726D
• Device Lot Number: KG2750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 08/20/2019
• Patient Sequence Number: 1