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

Catalog Number	J260H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 1/27/2025.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.Additional information was requested, the following was obtained: - did the reported happen in one case, same patient/same procedure, or more? how many times? - how many devices demonstrated the alleged deficiency on each involved patient event? - when did the needle detach or pop 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)? - can you identify the lot number of the product used? - what is the procedure name and date? - was there any adverse patient consequence(s) or subsequent medical/surgical intervention? - is the device or samples from the same lot available to return for analysis? - please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep) this was an obstetrical or.The team noted 4 pop offs and there are 23 unopened packages left in the box.The box is stored away ¿ can send back box.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.D4: udi: the expiration and manufactured date is currently not available.Therefore, the full udi is currently not available.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.It was reported that several pop offs during an or.Product replaced with a new box of the same product.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 2/25/2025 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.The following information was received: correct event date is jan 2 2025 (wrong year) returned will be 23 eches left in box 4 sutures had needle pop-offs.23 being returned.
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.Additional information: h6, d9, h3.H3 investigation summary: the product was returned to ethicon for evaluation.One unused open sample was received for analysis.Product code j260h.Upon initial inspection, no issues related to the pull-off needle were observed in the returned sample.The needles were examined, and the swage and attachment area appeared as expected.This product code j260h 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.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 no issues related to pull-off needle were 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.H3 investigation summary: the product was returned to ethicon for evaluation.One open box with twenty-three representative unopened was received for analysis.Product code j260h.The complaint sample was not received for evaluation.Upon initial inspection of the samples, no external damages were evident on the exterior packaging.Following the sampling plan, a visual inspection was conducted on thirteen samples.The swage and attachment areas appeared as expected.The sutures were dispensed without problems and examined along the strand to detect any issue related no defects were observed during evaluation.A functional test was performed using instron equipment and the pull force result was above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted.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 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.

• Brand Name: VCL CT BRD UD 27IN 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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21241732
• Report Number: 2210968-2025-00973
• Device Sequence Number: 8440017
• Product Code: GAM
• UDI-Device Identifier: 10705031038332
• UDI-Public: (01)10705031038332(17)290630(10)1024JX
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2025

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: J260H
• Device Lot Number: 1024JX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Supplement Date Received by Manufacturer: 01/30/2025; 03/27/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 02/25/2025; 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2024
• 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