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).A manufacturing record evaluation was performed for the finished device mlm317 batch number, and no non-conformance were identified.Additional information was requested and the following was received: were both devices vcp304h and vcp503g used in this procedure? yes.Any patient consequences and what medical / intervention was provided to manage them? no.Device return status / follow up? the products will be returned for investigation.Event reported via mw 2210968-2019-88393.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on an unknown date and suture was used.The needle and suture were detached during the surgery.A like device was used to complete the procedure.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
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.

• Brand Name: VCL+ UD 18IN 5-0 S/A P-2 PRM
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1210 ward avenue; west chester PA 19380
• MDR Report Key: 9157934
• Report Number: 2210968-2019-88394
• Device Sequence Number: 16625452
• 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): 09/10/2019

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: 09/30/2023
• Device Catalogue Number: VCP503G
• Device Lot Number: MLM317
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 11/11/2019
• Patient Sequence Number: 1