MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 36IN 1 S/A CTB-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCPB947H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device phz679 batch number, and no non-conformance's 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 the patient underwent an unknown ob-gyn surgery on (b)(6) 2020 and suture was used.While using a needle-suture, the suture was detached from the needle during continuous suturing on the myometrium.It was not a control release needle.Further details are not provided.There were no adverse consequences to the patient.

• Brand Name: VCL+ UD 36IN 1 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: 9783096
• Report Number: 2210968-2020-01718
• Device Sequence Number: 19495646
• Product Code: GAM
• UDI-Device Identifier: 10705031056749
• UDI-Public: 10705031056749
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/06/2020

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: 06/30/2024
• Device Model Number: VCPB947H
• Device Catalogue Number: VCPB947H
• Device Lot Number: PHZ679
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 03/03/2020
• Patient Sequence Number: 1