MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 0 S/A CTB-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCPB340H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a patient underwent their second cesarean section surgery on (b)(6) and suture was used.It was reported that the problem of pulling off suture needle had happened.The procedure was completed using a new like device and there were no adverse patient consequences reported.No additional information could be provided.

• Brand Name: VCL+ VIO 27IN 0 S/A CTB-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10986267
• Report Number: 2210968-2020-09818
• Device Sequence Number: 3299775
• Product Code: GAM
• UDI-Device Identifier: 10705031056398
• UDI-Public: 10705031056398
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/19/2020

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: 07/31/2024
• Device Model Number: VCPB340H
• Device Catalogue Number: VCPB340H
• Device Lot Number: PJZ141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 12/10/2020
• Patient Sequence Number: 1
• Patient Age: 24 YR