MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 8X18IN 2-0 S/A CT-2 CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J726D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2020
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 related to the reported complaint condition were identified.A needle of product code j726, lot # qemejt was received for evaluation.During the visual inspection of a detached needle, the swage and attachment area were noted to be as expected and no suture remnant was noted into the barrel hole.The suture was not received to determine the assignable cause and no functional tests could be performed.No conclusion could be reached as the needle was detached from the suture.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Events were submitted via 2210968-2020-09090 (1st sample).
Event or Problem Description
It was reported that a patient underwent an unknown surgery on (b)(6) 2020 and suture was used.Upon evaluation, an extra needle was found detached.There were no adverse patient consequences reported.

• Brand Name: VCL CT BRD VIO 8X18IN 2-0 S/A CT-2 CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11038030
• Report Number: 2210968-2020-10096
• Device Sequence Number: 13714798
• Product Code: GAM
• UDI-Device Identifier: 10705031042568
• UDI-Public: 10705031042568
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/25/2020

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: 04/30/2025
• Device Model Number: J726D
• Device Catalogue Number: J726D
• Device Lot Number: QEMEJT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 12/18/2020
• Patient Sequence Number: 1