MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 30IN 6-0 D/A BV-1 EP; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	EP8709H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4) additional information: h6 component code: g07002 - device not returned.Additional information has been requested however not received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.It was reported that "vascular surgeons are saying is snapping and faulty." please confirm the number of patients affected by this alleged deficiency? have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).If no, please create a new pc file for each patient/event.Please provide information requested below for each patient/event.What is the procedure name(s) and date(s)? can you identify the lot numbers and product code of the product that was used? how many devices demonstrated the alleged deficiency? how many devices are available to be returned for product analysis? when did the alleged deficiency happened (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)? were there patient consequences? if yes, please specify.Please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.Please 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).We have received additional product not reported for this complaint: quantity 1 / ep8709h; lot# 104e5j please advise if this product: is to be added to this complaint for breakage? is to be added as a new complaint and provide details? or is to be discarded as it was returned in error? a manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.The single complaint was reported with multiple events.There are no additional details regarding the additional events.The device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.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 a patient underwent an unknown procedure on an unknown date and suture was used.Vascular surgeons are saying is snapping and faulty.Additional information has been 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, 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, and the following was obtained: quantity 19 / ep8709h - ; lot# 101gj9 which was initially reported for this complaint.However, we have received additional product not reported for this complaint: quantity 1 / ep8709h; lot# 104e5j please advise if this product: is to be added to this complaint for breakage? is to be added as a new complaint and provide details? or is to be discarded as it was returned in error? yes there should be the box of sutures sent for the complaint.The hospital stated the multiple sutures broke from this box.This was reported in the same complaint to us.Rep reported that ¿there should be the box of sutures sent for the complaint¿.The box that the rep is referring to seems to be related to the 19 samples of lot 101gj9 returned inside one open box.It was also reported that ¿multiple sutures broke from this box¿.Pc-(b)(4) was created to capture an ambiguous number of sutures lot 101gj9 that broke.
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.H3 investigation summary: the product was returned to ethicon for evaluation.One open box with nineteen unopened samples was received for analysis.Product code ep8709h.As per the sampling plan, a visual inspection was performed on thirteen samples, and no defects were found on the packages.The packets were opened, and the swage and attachment area were noted as expected.The sutures were dispensed without problems and examined along of the strand and no issues related to breakage sutures or anomalies were observed during the evaluation.Also, a functional test was performed using instron equipment and tensile force 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.

• Brand Name: PRLNE BLU 30IN 6-0 D/A BV-1 EP
• Common Device Name: SUTURE, NONABSORBABLE, 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: 21424000
• Report Number: 2210968-2025-01846
• Device Sequence Number: 7764330
• Product Code: GAW
• UDI-Device Identifier: 10705031208308
• UDI-Public: (01)10705031208308(17)290531(10)101GJ9
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/25/2025

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: EP8709H
• Device Lot Number: 101GJ9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2025
• Supplement Date Received by Manufacturer: 02/26/2025; 04/25/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 03/24/2025; 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2024
• 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