MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 24IN 8-0 D/A BV130-5 EP; SUTURES - NON-ABSORBABLE

Catalog Number	EP8732H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
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: 1.How many devices demonstrated the alleged deficiency on each involved patient event? on one patient the suture broke without much tension happened 3 times with 2-3 suture 2.Did three sutures broke in total in one patient after 2 - 3 tissue passges? were three patients involved and 2 - 3 sutures broke per patient? a total of 3 threads in one patient.Affected 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.Our failure analysis lab received extra products with reference to this complaint, it was received: product code: (33) ep8732h.Product lot/batch: (32) 1098e4 / (1) 10adpc.1.Could you please clarify if extra device belongs to this complaint? 2.If not, could you please clarify if the extra received product belongs to a different complaint? if so, can you please provide the complaint number.3.If the device was not reported before, please provide more details of device malfunction.4.If the product doesn¿t belong to any complaint, please let us know so we can discard it or advise if the product is required to be returned.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 aortocoronary vein bypass procedure on an (b)(6) 2026 and suture was used.Durind an aortocoronary vein bypass surgery thread pull off during tissue passage approximately 3-5 cm from the needle without pressure.Tissue arteries (thoracic wall arteries).The surgery was completed using another technique.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 3/18/2026.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.H6 component code: g07002 no device problem found.Additional information: d9, h3, h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, the following was obtained: product code: (33) ep8732h product lot/batch: (32) 1098e4 / (1) 10adpc 1.Could you please clarify if extra device belongs to this complaint? no, after a phone call with the sales representative , he informed us that ms.Rehm, the operating room manager, had given it to him by mistake.2.If not, could you please clarify if the extra received product belongs to a different complaint? if so, can you please provide the complaint number.No 3.If the device was not reported before, please provide more details of device malfunction.N/a 4.If the product doesn¿t belong to any complaint, please let us know so we can discard it or advise if the product is required to be returned.You can discard it h3 investigational summary: the product was returned to eth for evaluation.Visual inspection revealed that one unopened sample was received for analysis.The product code ep8732h is double armed.The product was returned for evaluation and, upon visual inspection, no external damages were observed on the packet.The packet was opened, and the swage and attachment area were noted as expected.The suture was 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 eth 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.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Additional h3 investigational summary: the product was returned to eth for evaluation.Visual inspection revealed that three sealed boxes each with thirty-six (36) unopened samples were received for analysis.Product code ep8732h.As per the sampling plan, a visual inspection was performed on thirty-two samples, no defects were found on the packages.The packets were open, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no issue related to breakage sutures or anomalies were observed during evaluation.Also, the functional test was performed using an instron equipment, and the pull force results were above the minimum requirements.As part of eth quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed 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.Additional h3 investigational summary: the product was returned to eth for evaluation.Visual inspection revealed that one open box with twenty- eight (28) unopened samples was received for analysis.Product code ep8732h.As per the sampling plan, a visual inspection was performed on thirteen (13) samples, no defects were found on the packages.The packets were open, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no issue related to breakage sutures or anomalies were observed during evaluation.Also, the functional test was performed using an instron equipment, and the pull force results were above the minimum requirements.As part of eth quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed 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: PRLNE BLU 24IN 8-0 D/A BV130-5 EP
• Common Device Name: SUTURES - NON-ABSORBABLE
• 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: 24378246
• Report Number: 2210968-2026-01725
• Device Sequence Number: 4942127
• Product Code: GAW
• UDI-Device Identifier: 10705031215948
• UDI-Public: (01)10705031215948(17)300731(10)10AHP6
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 02/18/2026

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: EP8732H
• Device Lot Number: 10AHP6
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2025
• 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