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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device batch qpbckq and no non-conformances were identified.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: what is the name of the procedure? fixation of a central venous line was there additional tissue damage as a result of finding the needle part? no.Did the needle fall into the patient? no.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2021 and suture was used.During the procedure, the needle broke during the performance of an attachment point of a central venous route.There were no adverse patient consequences.No additional information was provided.

• 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: 12131643
• Report Number: 2210968-2021-06061
• Device Sequence Number: 4411331
• 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): 06/14/2021

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: 11/30/2025
• Device Model Number: X834H
• Device Catalogue Number: X834H
• Device Lot Number: QPBCKQ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 07/07/2021
• Patient Sequence Number: 1