MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 18IN 7-0 S/A P-1 PRM; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J488G
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).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Investigation summary: it was reported a breakage needle issue.One opened box with seven unopened samples was received for analysis.The complaint sample was not returned for evaluation.During the visual inspection of seven samples, no defects were found on the packages.The samples were opened and the swage and attachment area were noted to be as expected; also, the tip and body of the needles were examined under magnification and no defects, damage or needle breakage were found.Besides, 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.According to the samples conditions, no performance - breakage needle was found.Representative samples returned to support investigation of 3 device issues captured in reports 2210968-2019-88076, 2210968-2019-88077.Analysis results have been included in reports for each.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the suture needle broke.It is unknown if another like device was used to complete the procedure.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: VCL CT BRD UD 18IN 7-0 S/A P-1 PRM
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 9116430
• Report Number: 2210968-2019-88078
• Device Sequence Number: 13898967
• Product Code: GAM
• UDI-Device Identifier: 10705031040410
• UDI-Public: 10705031040410
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/30/2019

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: 02/29/2024
• Device Catalogue Number: J488G
• Device Lot Number: PCZ304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2019
• Initial Report FDA Received Date: 09/25/2019
• Patient Sequence Number: 1