MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 5IN 8-0 S/A BV130-5; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J401G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.The following information was requested, but unavailable: was the needle removed from the patient? no further information is available.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a patient underwent an eyelid ptosis operation procedure on (b)(6) 2021 and barbed suture was used.The suture detached from the needle, and it was not a control release needle.No adverse patient consequences were reported.Additional information was requested.
Event or Problem Description
It was reported that a patient underwent an eyelid ptosis operation procedure on (b)(6) 2021 and suture was used.The suture detached from the needle, and it was not a control release needle.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: VCL CT BRD VIO 5IN 8-0 S/A BV130-5
• 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; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14253032
• Report Number: 2210968-2022-03162
• Device Sequence Number: 14552343
• Product Code: GAM
• UDI-Device Identifier: 10705031039599
• UDI-Public: 10705031039599
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2022

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: 11/30/2025
• Device Model Number: J401G
• Device Catalogue Number: J401G
• Device Lot Number: QPMHEU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2022
• Supplement Date Received by Manufacturer: 04/15/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown