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 Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	06/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Attempts have been made to retrieve the device.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.Additional information was requested, and the following was obtained: - were x-rays taken to locate the needle? - yes.- was there any additional tissue damage resulting from the search for the needle piece? - no tissue damage noted.Additional surgical incision for removal was necessary though.Healing well with no complications noted.- does a fragment of the needle remain in the patient¿s tissue? no.¿ what is the surgeon's opinion of the potential consequences for the patient? - none noted - what is the current status of the patient? - doing well per 1 week follow up visit.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.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.
Event or Problem Description
It was reported that a patient underwent a vaginal delivery procedure on (b)(6) 2025 and a suture was used.During vaginal delivery the provider repairing a vaginal laceration and ran a suture line.The needle became detach and it lock in to the peritoneum so they need to take the patient to operating room to have it remove.No adverse patient consequences were reported.Additional information was requested.
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.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.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? what instruments were used to grasp the needle? where was the needle grasped during use? was the patient brought to the operating room the same day to have the needle removed? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? has the product been returned? if so, please provide the return date and tracking information.
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: a2, a3a, a4, b7, d9, h3, h6.Additional information was requested, and the following was obtained: please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure: 26 years old/ female/ 62.5kg/ 29.21kg/m2.On what tissue was the suture used? vaginal/labial tissue.What was the tissue condition (normal, thin, calcified, fragile, diseased)? normal.How was the suture placed (interrupted or continuous)? continuous.What instruments were used to grasp the needle? not sure.Where was the needle grasped during use? i don't know the answer to this.Was the patient brought to the operating room the same day to have the needle removed? yes.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? no.Other relevant patient history/concomitant medications? no.What is the physician¿s opinion as to the etiology of or contributing factors to this event? not sure--- cnm states that part way through the repair, it just "popped off".What is the patient's current status? doing well- no further complications noted.Has the product been returned? if so, please provide the return date and tracking information.Remaining products from the same box are being/have been returned.Needle from pathology was discarded.H6 component code: g07002 no device problem.Additional h3 investigation summary.The product was returned to ethicon for evaluation.Four representative unopened samples were received for analysis.Product code j258h.The complaint sample was not received for evaluation.Upon initial inspection of the samples, no external damages were observed on the external packets.In order to evaluate the conditions of the returned samples, the packets were opened, and no defects were detected.The swage and attachment area were noted to be 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 results were above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted.It should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.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.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• 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: 22610133
• Report Number: 2210968-2025-08612
• Device Sequence Number: 5457506
• Product Code: GAM
• UDI-Device Identifier: 10705031038295
• UDI-Public: (01)10705031038295(17)280531(10)TGMDQQ
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: J258H
• Device Lot Number: TGMDQQ
• 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: 06/25/2025
• Supplement Date Received by Manufacturer: 07/29/2025; 08/04/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 07/31/2025; 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Weight: 62 KG