MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 27IN 3-0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J258H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by distributor that they have a box of suture that 2 different providers used, and the needle broke off and a knot came undone for another one.They removed the suture from use.Got done closing the subcutaneous tissue.Tied the knot and moved on to the skin layer and the knot had just come undone.This happened twice on the patient using the same suture.On a different case the needle just popped off the suture.There was 3 minutes delay to these activities because they had to keep repeating the same part of the procedure.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #(b)(4).Date sent to the fda: 7/24/2025.H6 component code: g07002 - device not returned 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, or its employees that the report constitutes an admission that the product, ethicon, 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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, the following was obtained: please answer the questions below regarding the suture which knot come undone twice ((b)(4).): what was the name of the procedure? c-section ¿ what was the procedure date? unsure ¿ what was used to complete the procedure? same product from a different unopened box ¿ were there any patient cosequences? delay in procedure, but no patient consequences ¿ was there any change in the patient¿s post-operative care due to the prolonged procedure? no ¿ is the device available to be returned for evaluation? if so, please provide the status of the return and any available tracking information.No please answer the questions below regarding the needle which popped off the suture ((b)(4).): ¿ what was the name of the procedure? c-section ¿ what was the procedure date? unsure ¿ when was the needle detached/pulled off from the suture (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? during use on patient ¿ did the needle fall into the patient? if yes, was the needle piece removed from the patient during the same procedure? no ¿ what was used to complete the procedure? did not change item, was at end of suturing ¿ were there any patient cosequences? delay in procedure, but no patient consequences ¿ was there any change in the patient¿s post-operative care due to the prolonged procedure? no ¿ is the device available to be returned for evaluation? if so, please provide the status of the return and any available tracking information.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.

• Brand Name: VCL CT BRD UD 27IN 3-0 S/A CT-1
• 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: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22587884
• Report Number: 2210968-2025-08568
• Device Sequence Number: 21180293
• Product Code: GAM
• UDI-Device Identifier: 10705031038295
• UDI-Public: (01)10705031038295(17)291231(10)10616P
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• Report Date (Section B): 07/24/2025

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: J258H
• Device Lot Number: 10616P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2025
• 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