MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 36IN 0 S/A CTB-1; COATED VICRYL* (POLYGLACTIN 910) SUTURE

Catalog Number	JB946H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).H6 component code: g07002 - no device problem found.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, and the following was obtained via: lot number? ubmhqq.Provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq).(b)(4).Please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.The device has been received at sukagawa and will be shipped.Please check rmao.Tracking number: (b)(4).H3 investigation summary: the product was returned to ethicon for evaluation.Fifteen unopened samples were received for analysis.Product code jb946, lot ubmhqq.As per the sampling plan, a visual inspection was performed on thirteen samples, the packets were opened, and the swage and attachment area was noted as expected.The sutures were dispensed without problems and examined along the strand no anomalies were observed during evaluation.The functional test was performed using instron equipment and the pull force result was above the minimum requirements.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.
Event or Problem Description
It was reported that a patient underwent an unknown surgery on an unknown date and suture was used.During the procedure, the suture came off from the base of the needle during use.It occurred twice in a row.It was not a control release needle.Further details are not provided from the hp.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 1/2/2025.H6 component code: g07002 no device problem found.H3 investigational summary: the product was returned to ethicon for evaluation.One needle and one suture were received for analysis.Upon visual inspection of the detached needle, the attachment condition was as expected.The barrel hole of the needle was examined with magnification, and no suture remnant was noted.The suture was inspected, and the insertion mark could not be observed in the extremes.In addition, body fluids were noted along of strand.As per the conditions of the returned sample, no functional test could be performed.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.No conclusion could be reached as to what caused the reported complaint.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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.

• Brand Name: VCL CT BRD UD 36IN 0 S/A CTB-1
• Common Device Name: COATED VICRYL* (POLYGLACTIN 910) SUTURE
• 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: 20878587
• Report Number: 2210968-2024-13057
• Device Sequence Number: 20784624
• Product Code: GAM
• UDI-Device Identifier: 10705031462441
• UDI-Public: (01)10705031462441(17)290131(10)UBMHQQ
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

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 Expiration Date: 01/31/2025
• Device Catalogue Number: JB946H
• Device Lot Number: UBMHQQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2024
• 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