MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 27IN 0 S/A SH; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J418H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint number: (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: was there any adverse consequence associated with the patient? was there any medical or surgical intervention performed (product removed; re-operation; re-closure; drainage)? if so, please specify.Could you tell me if there was a prescription for steroids or antibiotics for the patient's recovery? if yes, please provide medication name, route and dose.What is the patient¿s current status? according with event description, the suture "looked like barbed suture", could you please provide more details? according with event description, "the vicryl started to come undone", could you please provide more details? is there evidence that could suggest that the reported suture was part of a product mix in the package? 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.Related to: 2210968-2022-02447, 2210968-2022-02448, and 2210968-2022-02449.
Event or Problem Description
It was reported that a patient underwent a urological procedure on (b)(6) 2022 and suture was used.During the procedure, the suture started to come undone.There were no patient consequences reported.Additional information was requested.

• Brand Name: VCL CT BRD UD 27IN 0 S/A SH
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14033289
• Report Number: 2210968-2022-02450
• Device Sequence Number: 6288201
• Product Code: GAM
• UDI-Device Identifier: 10705031039704
• UDI-Public: 10705031039704
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/06/2022

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: 06/30/2026
• Device Model Number: J418H
• Device Catalogue Number: J418H
• Device Lot Number: RHMPUU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2021
• 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
• Patient Sex: Unknown