MAUDE Adverse Event Report: ETHICON INC. VICRYL PLUS UND 70CM M2; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP416H
Medical Device Problem Code	Material Separation (1562)
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 (b)(4), and no non-conformances were identified.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please clarify event details: ¿suture needles missing two separate times from suture¿ did the suture separate from the needle prior or during use on the patient? how many devices were involved in this single procedure? when did the event occurred? name of procedure? device return status/follow up? 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.
Event or Problem Description
It was reported that the patient underwent an unknown procedure in 2019 and the suture was used.It was also reported that the needle was missing from suture.There were no patient consequences reported.

• Brand Name: VICRYL PLUS UND 70CM M2
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9411144
• Report Number: 2210968-2019-90532
• Device Sequence Number: 16876482
• Product Code: GAM
• UDI-Device Identifier: 10705031078147
• UDI-Public: 10705031078147
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/13/2019

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: 06/30/2024
• Device Catalogue Number: VCP416H
• Device Lot Number: PH7597
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 12/04/2019
• Patient Sequence Number: 1