MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 36IN 5-0 D/A BB; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8580H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2024
Type of Reportable Event	Malfunction
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.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 kindly confirm the number of devices used or pull off during this single procedure? the following was obtained: -qty of product involved of (b)(4).-qty to be returned of (b)(4).H3 analysis: the product was returned to ethicon for evaluation.The returned product determined that it was received, thirteen unopened samples that pertained to the product code 8580h.This product code is double armed.In order to evaluate the condition of the returned samples, the packets were opened.The swage and attachment area were noted to be 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 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.This report is not intended to deny that you experienced a problem with the device.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.D4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
It was reported that a patient underwent a unknown cardiovascular procedure on (b)(6) 2024 and suture was used.During the procedure, the needle had come off during suturing.No pieces were left inside the patient.It was not a control release needle.There were no adverse consequences 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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
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 information was requested, and the following was obtained: please kindly confirm the number of devices used or pull off during this single procedure? one.

• Brand Name: PRLNE BLU 36IN 5-0 D/A BB
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• 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: 19761887
• Report Number: 2210968-2024-07306
• Device Sequence Number: 8778152
• Product Code: GAW
• UDI-Device Identifier: 10705031017337
• UDI-Public: (01)10705031017337(11)231127(17)281031(10)TMBHSP
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2024

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: 8580H
• Device Lot Number: TMBHSP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2024
• Supplement Date Received by Manufacturer: 07/18/2024; 07/18/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 08/13/2024; 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown