MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 24IN 7-0 D/A RB-3; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8206H
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
Additional Manufacturer Narrative
Product complaint # (b)(4) h3 investigation summary: the product was returned to ethicon for evaluation.Twelve unopened overwrap packets were received for analysis.Product code 8206h is double armed.In order to evaluate the condition of the returned samples, the packets were opened, and the swage and attachment area was noted to be 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.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.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.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 clarify, with the second product involved, when was the needle 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)? please specify.Please provide the source or name and title of external person providing answers to follow-up.(external person submitting answers to sales rep) additional h11: was surgery delayed due to the reported event? no, action taken when event occurred? the suture was swapped out for the same suture of a different lot number, was procedure successfully completed? yes, were fragments generated? no, if yes, were they removed easily without additional intervention? unknown, if no, explain: the suture was discarded and the same suture of a different lot number was used, patient status/ outcome / consequences no, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? no patient consequences, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: no, is the patient part of a clinical study unknown, (b)(4), device property of none, device in possession of none.
Event or Problem Description
It was reported that a patient underwent a cardiovascular procedure in 2025 and suture was used.During the procedure, it was reported to the sales rep by the surgeon that the needle popped off while suturing during a cardiac surgery (pulling the extra suture taught on a running stitch).The case continued and the suture was swapped out with the same suture of a different lot number.The patient was not harmed.It happened on 2 packs in a row.One of the needles flew to the end of the sterile field.The procedure was completed successfully with no adverse consequences for the patient.Devices were returning.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.Corrected data: g3.Date received by manufacturer: 7/29/2025.

• Brand Name: PRLNE BLU 24IN 7-0 D/A RB-3
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• 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: 22893657
• Report Number: 2210968-2025-09809
• Device Sequence Number: 14948927
• Product Code: GAW
• UDI-Device Identifier: 10705031013322
• UDI-Public: (01)10705031013322(17)46691(10)SMMMDT
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• 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
• Report Date (Section B): 08/26/2025

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: 8206H
• Device Lot Number: SMMMDT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2022
• 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