MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 36IN 0 S/A CT; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J958H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot number pe2285, and no non-conformance's related to the reported complaint condition were identified.Investigation summary: an opened box with twenty-seven unopened samples of product code j958h, lot # pe2285 were received for evaluation.The complaint sample was not received for evaluation.During the visual inspection of unopened samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.No needles breakage was observed.The sutures were dispensed without problems and examined along of the strand and no defects were observed.Also, the samples were tested by resistance test to needle and met the requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the conditions of the samples received, no breakage needle were found.
Event or Problem Description
It was reported that the patient underwent c-section on an unknown date and suture was used.During the procedure, the tip of the needle broke off in the patient.The tip was retrieved and found in the needle box.It was not reported how the procedure was completed.There were no adverse patient consequences reported.

• Brand Name: VCL CT BRD UD 36IN 0 S/A CT
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9557616
• Report Number: 2210968-2020-00144
• Device Sequence Number: 19416899
• Product Code: GAM
• UDI-Device Identifier: 10705031043725
• UDI-Public: 10705031043725
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/11/2019

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: 04/30/2024
• Device Catalogue Number: J958H
• Device Lot Number: PE2285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 01/07/2020
• Patient Sequence Number: 1