MAUDE Adverse Event Report: VCL CT BRD UD 18IN 5-0 S/A PS-3 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J500G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2021
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.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: have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).(b)(4).What is the procedure name? no information.What is the procedure date? 12th october.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription medication)? no.If medication was required, please clarify if it was prescribed by a physician.? no.What is the most current patient status? not known.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Events reported in 2210968-2021-10914.
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 came off of the swage.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: VCL CT BRD UD 18IN 5-0 S/A PS-3 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• MDR Report Key: 12752795
• Report Number: 2210968-2021-10913
• Device Sequence Number: 17280765
• Product Code: GAM
• UDI-Device Identifier: 10705031040670
• UDI-Public: 10705031040670
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 11/04/2021

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: J500G
• Device Catalogue Number: J500G
• Device Lot Number: QMMHET
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 11/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1