MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 30"(75CM) 6-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	EP8711H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).H6.Component code: g07002 - device not returned.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.When did the needle detach or pull 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)? please provide details for each involved device.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 an unknown cardiovascular procedure on (b)(6) 2024 and suture was used.The suture was detached from the needle easily.We received a request to investigate 5 products in this lot, as they were wrong in a row.The five used products were discarded.We asked the nurse in charge, spd, and the distributor to make sure to keep the product the next time when they felt something was wrong.They are using with different lots of products now.It was not a control release needle.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 information: d4: full udi currently unavailable since the exact lot of the suspected device cannot be determined.Corrected information: d4, h4 - the actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: batch uabjpp mfg date: 1/31/2024, exp date: 12/31/2028; batch uabbus mfg date: 1/12/2024, exp date: 12/31/2028; batch 103117 mfg date: unknown, exp date: 7/31/2029.Additional information was requested, and the following was obtained: when did the needle detach or pull 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)? during use on patient in all 5 device.Please provide details for each involved device.Please perform and document the follow-up attempt for product return.Please document the shipment tracking number in the notes or rmao sections.The device has been received and will be shipped.
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 d4, h4 - the actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: batch uabjpp, mfg date: 1/31/2024, exp date: 12/31/2028.Batch uabbus, mfg date: 1/12/2024, exp date: 12/31/2028.Batch 103117, mfg date: 8/24/2024, exp date: 7/31/2029.In addition, a review of the manufacturing record evaluation for the possible batch numbers was performed for the finished device lot, and no non-conformances were identified.Additional h6 component code: g07002 no device problem.Additional h3 investigation summary: the product was returned to ethicon for evaluation.Sixteen representative unopened samples were received for analysis.Product code ep8711h.The complaint sample was not received for evaluation.Upon initial inspection of the samples, no external damages were observed on the external packets.As per the sampling plan, a visual inspection was performed on thirteen samples.The packets were opened, and 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 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.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.The product was returned to ethicon for evaluation.Three representative unopened samples were received for analysis.Product code ep8711h.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.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.The product was returned to ethicon for evaluation.Twelve representative unopened samples were received for analysis.Product code ep8711h.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.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: PROLENE SUTURE 30"(75CM) 6-0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20905752
• Report Number: 2210968-2024-13271
• Device Sequence Number: 4008001
• Product Code: GAW
• UDI-Device Identifier: 10705031231313
• UDI-Public: (01)10705031231313(17)281231(10)UABHLJ
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/12/2025

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: EP8711H
• Device Lot Number: UABHLJ
• 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: 12/02/2024
• Supplement Date Received by Manufacturer: 12/12/2024; 01/20/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 01/07/2025; 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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