MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 8X18IN 1 S/A CT-1 CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J841D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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: please confirm the specific number of patient events: 3.Have any of these events been previously reported to ethicon? no.For each patient event please provide: event date: (b)(6) 2021.(b)(6) 2021.(b)(6) 2021.Procedure: plastics, general, general.Event description: needles are falling off pop offs before use is over.Was there any adverse patient outcome? no.Device return status: na: told them to hold & red bag any other products that continue to not meet quality.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's related to the reported complaint condition were identified.Note: events reported via 2210968-2021-07463, 2210968-2021-07461, and 2210968-2021-07464.
Event or Problem Description
It was reported that a patient underwent a plastic surgery on (b)(6) 2021 and suture was used.During the procedure, the suture got detached from the needle.There were no patient consequences reported.Additional information was requested.

• Brand Name: VCL CT BRD UD 8X18IN 1 S/A CT-1 CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12338747
• Report Number: 2210968-2021-07462
• Device Sequence Number: 4980710
• Product Code: GAM
• UDI-Device Identifier: 10705031043244
• UDI-Public: 10705031043244
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/19/2021

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: No Information
• Device Expiration Date: 02/28/2025
• Device Model Number: J841D
• Device Catalogue Number: J841D
• Device Lot Number: QCMHBM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 08/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1