MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 36IN 2-0 S/A CTB-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	JB945
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The following information was requested, but unavailable: did the needle suture detachment occur during use on the patient or before use on the patient.Please specify for each of the 2 involved devices.=>no further information is available.Could you please provide the lot number? =>no further information is available.Was the procedure completed successfully? what was used to complete it? =>no further information is available.Procedure name? =>no further information is available.No further information will be provided.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.Events reported via: 2210968-2021-08358.
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 suture got detached from the needle.There were no patient consequences reported.Additional information was requested.

• Brand Name: VCL CT BRD UD 36IN 2-0 S/A CTB-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12460564
• Report Number: 2210968-2021-08359
• Device Sequence Number: 14434138
• Product Code: GAM
• UDI-Device Identifier: 10705031044067
• UDI-Public: 10705031044067
• 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: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/18/2021

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 Model Number: JB945
• Device Catalogue Number: JB945
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 09/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1