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

Model Number	VCPB947H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on an unknown date and suture was used.The suture was broken during use.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 04/27/2020.A manufacturing record evaluation was performed for the finished device batch phz679 and no non-conformances were identified.Additional h3 investigation summary: it was received for analysis an empty opened foil and a used needle of product code vcpb947h, lot phz679.The failed sample was not returned for evaluation.As no suture was returned for evaluation, we are unable to investigate further to the issue.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.

• 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: 9930214
• Report Number: 2210968-2020-02683
• Device Sequence Number: 3218383
• 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,Followup
• Report Date (Section B): 03/09/2020

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 04/27/2020
• Patient Sequence Number: 1