MAUDE Adverse Event Report: ETHICON INC. PRLNE HS BLU 24IN 5-0 D/A BV-1 EP; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	EPH9702H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
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.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 procedure on an unknown date and suture was used.The problem of the suture pulling off of the needle happened in surgery.The needle did not fell into the patient.Changed another one to complete the surgery.No adverse patient consequences were reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 9/25/2024.H6 component code: g07002 no device problem found.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.H3 investigational summary: the product was returned to ethicon.One empty labeled winding former and a needle suture piece were received for analysis that belongs to product code eph9702h.This product code is double-armed.During the visual inspection of the returned sample, no pull-off was observed in the sample.The swage and attachment area were noted as expected.The suture was examined, and damage (crushed) was observed in some parts of the suture.Besides that, the end was found to be cut probably caused by a surgical instrument, and the other section of the sample was not returned for evaluation.Per the condition of the returned sample, the functional test could not be tested.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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.

• Brand Name: PRLNE HS BLU 24IN 5-0 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.-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: 20035655
• Report Number: 2210968-2024-08783
• Device Sequence Number: 19601939
• Product Code: GAW
• UDI-Device Identifier: 10705031233478
• UDI-Public: (01)10705031233478(11)230811(17)280731(10)TJBDAT
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 09/25/2024

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: EPH9702H
• Device Lot Number: TJBDAT
• 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: 07/25/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown