MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 36IN 2-0 S/A V-34; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP517H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device ml2120, and no non-conformances were identified.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that a patient underwent a cesarean section under epidural anesthesia on (b)(6) 2020 and suture was used.During the procedure, the suture pulled off the needle when it was sewing the uterus.Changed another one to complete the surgery.There were no adverse patient consequences reported.No additional information could be provided.

• Brand Name: VCL+ VIO 36IN 2-0 S/A V-34
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9938163
• Report Number: 2210968-2020-02781
• Device Sequence Number: 10951372
• Product Code: GAM
• UDI-Device Identifier: 10705031054028
• UDI-Public: 10705031054028
• 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
• Report Date (Section B): 03/16/2020

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: 09/30/2023
• Device Model Number: VCP517H
• Device Catalogue Number: VCP517H
• Device Lot Number: ML2120
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 04/08/2020
• Patient Sequence Number: 1