MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 8X18IN 0 S/A CTXB CR; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	JB724
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (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.Additional information was requested and the following was provided: * when did the needle detach or pull off from the suture (in the package, during removal from the package, during handling prior to using on the patient, or during use on the patient) ? =>in the package.H3 analysis summary: the product was returned to ethicon for evaluation.One winding former with seven needle suture combinations, one detached needle, and one suture was received for analysis.Product code jb724 which is a control release and requires eight strands per packet.Upon visual inspection of the returned sample, it was noted that the needle from slot #8 was detached from the suture.The suture was examined, and short insertion was observed.Overall, the combination of the needle/suture was found detached since the insertion of the suture did not meet with requirement.In addition, the needle-suture combinations were visually inspected, and no anomalies or issues related to pull-off were observed during the evaluation.The product code jb724 contains an absorbable suture.Since the sample was received open, the functional test could not be performed due to undetermined exposure time to the environment.Based on the information currently available, short insertion issue was identified as pull out during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.
Event or Problem Description
It was reported that, in the package, one needle out of 8 had been detached from the suture.It was a control release needle.There were no adverse consequences to the patient.Based on the information currently available, short insertion issue was identified as pull out during the investigation of the sample received.

• Brand Name: VCL CT BRD UD 8X18IN 0 S/A CTXB CR
• 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: 20914885
• Report Number: 2210968-2024-13354
• Device Sequence Number: 8581608
• Product Code: GAM
• UDI-Device Identifier: 10705031043954
• UDI-Public: (01)10705031043954(17)280531(10)TGMCMH
• 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

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: JB724
• Device Lot Number: TGMCMH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2023
• 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