MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 18IN 4-0 S/A P-3 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J494G
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.The 5-0 and 4-0 vicryl sutures: when was the sutures ripped in the middle of the suture and the needles felled off (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify.Do you have any photos available for visual analysis? the 5-0 nylon needles: it was reported that the needles are coming in irregular sizes, 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? do you have any photos available for visual analysis? please provide the product code and lot number if available for the 5-0 nylon sutures that have come in irregular sizes.Please provide the name of the healthcare facility at which the event took place.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.Component code: g07002 device not returned.Related events captured via: 2210968-2024-03432, 2210968-2024-03434, 2210968-2024-03435.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on an unknown date in 2024, and suture was used.The healthcare professional reported that they have been experiencing issues with the 5-0 vicryl sutures, 4-0 vicryl sutures, and 5-0 nylon.The 5-0 and 4-0 vicryl sutures are ripping in the middle of the suture and the needles are falling off.The 5-0 nylon needles are coming in irregular sizes.There was no patient consequences were reported.Additional information was requested.

• Brand Name: VCL CT BRD UD 18IN 4-0 S/A P-3 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19006088
• Report Number: 2210968-2024-03433
• Device Sequence Number: 9457445
• Product Code: GAM
• UDI-Device Identifier: 10705031040526
• UDI-Public: 10705031040526
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial

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 Catalogue Number: J494G
• Device Lot Number: TPMCXQ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2024
• Initial Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2023
• 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