MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 30IN 0 S/A SH; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	X834H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(4).Attempts have been made to retrieve the device.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.Additional information was requested and the following was obtained: clarification of the initial description - in (b)(6) 2021 in the vascular radiology room, when performing of a suture, the thread pulled off from the needle.It was necessary to change the thread in order to perform the suture.In the declaration, the customer report that this is the only issue of this type reported for this device.Please provide procedure name bliary drainage.Please clarify if there were any adverse patient consequences due to this events? no patient consequences.The needles could always be withdrawn in the correct direction of the gesture (allowing the realization of the stitch) or by withdrawing them.Consequences: need for repunction.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent a biliary drainage procedure on (b)(6) 2021 and suture was used.During the procedure, the thread pulled off from the needle.Another like device was used to complete the procedure.There were no adverse patient consequences reported.Additional information was requested.

• Brand Name: EB EXC GRN 30IN 0 S/A SH
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12252812
• Report Number: 2210968-2021-06813
• Device Sequence Number: 3112679
• Product Code: GAT
• UDI-Device Identifier: 10705031058064
• UDI-Public: 10705031058064
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K946173
• 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): 07/02/2021

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: 10/31/2025
• Device Model Number: X834H
• Device Catalogue Number: X834H
• Device Lot Number: QMBDPC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1