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	10/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4) additional information: h6 component code: g07002 - device not confirmed.Additional information provided: surgeon reported that he has experienced premature needle disengagement from the 7-0 prolene suture on an rb-3 (item # 8206) many times over the past few months.He explained that it causes a several minute delay each time it happens because he has to start over on the vessel anastomosis.While the nurses haven't saved the needles involved in the complaint, he had obtained 3 sutures from the same box/lot # from which those in question were pulled.Surgeon stated that it seems like there is a manufacturing problem with some of these sutures.Additional information has been requested and received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.Did the event occur during one or multiple patient procedures? multiple patient procedures what is the total number of procedures? the doctor didn't give a specific number.Have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).No.This was the first time the complaint was reported to me if this event occurred in multiple procedures, please provide information requested above for each patient event: what is the procedure name(s) and date(s)? unknown what is the quantity involved per procedure 1.Was there any adverse patient consequence(s) or subsequent medical/surgical intervention? it was stated that because of the detachment the procedure took a few extra minutes because the vessel anastomosis had to be restarted.When was the needle detached/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.It detached while being used on the patient.Surgeon reported that it came off when pulling the needle through the tissue after making 1-3 passes through the tissue normally.Are any devices available to be returned for evaluation? if so, please provide the status of the return and any available tracking information.3 of the same lot number in original packaging were shipped out today using shipper kit sent to me.Estimated delivery (b)(6).Please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep) these answers are provided based on the original information given to me by surgeon providing the complaint.H3 evaluation: product received for analysis.The product was returned to ethicon for evaluation.Three unopened samples were received for analysis.Product code.In order to evaluate the condition of the returned samples, the packets were opened.The swage and attachment area were noted as expected.The sutures were dispensed without problems and examined along the strand no anomalies were observed during the evaluation.The functional test was performed using intron 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.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot number, and no related 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 a patient underwent an unknown cardiovascular procedure on (b)(6) 2024 and suture was used.Surgeon has experienced premature needle disengagement from the suture.He explained that it causes a several minute delay each time it happens because he has to start over on the vessel anastomosis.The procedure was delayed by four minutes.The procedure was completed successfully with no adverse consequences for the patient.Devices were returning.Additional information has been requested.

• 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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20762059
• Report Number: 2210968-2024-12382
• Device Sequence Number: 18283157
• Product Code: GAW
• UDI-Device Identifier: 10705031013322
• UDI-Public: (01)10705031013322(17)270630(10)SHMCAQ
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/22/2024

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: SHMCAQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2022
• 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