MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 24IN 6-0 D/A BV-1 EP; SUTURES - NON-ABSORBABLE

Catalog Number	EP8805H
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During an unknown surgery, there is a sense of discomfort to the suture of the joint part between the suture and needle (it looks like it is swollen more than usual), so the use was stopped for the patient.It was not a control release needle.Another product was used to complete the case.There were no adverse consequences to the patient.Additional information was requested.
Additional Manufacturer Narrative
Product complaint (b)(4).Date sent to the fda: 4/25/2025.H6 component code: g07002 - device not returned 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.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: can you please provide the lot number of the product involved? sjbadl.Please clarify what you mean by "it looks like it is swollen"? the suture of the connection part with the needle seemed to be thicker.Any.Can you provide any pictures of the product involved? no were there any issues with the suture? or needle? suture please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq) (b)(4).Please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.The device has been received at sukagawa and will be shipped.Please check rmao.Tracking number:(b)(4).H3 investigational summary: the product was returned to ethicon for evaluation.One over wrap packet, an detached needle end a needle suture piece were received for analysis.The product code ep8805h this pertain a double armed.During a visual inspection of the return sample, the end of the suture piece was noted to be cut possible caused for a surgical instruments.The suture was measured en the federal gauge and the result met the requirements.In addition, the detached needle was observed broken at the swage area due to a incorrect swage.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Based on the information currently available, an incorrect swage and broken needle was identified during the investigation of the sample received.This product issue will be addressed through ethicon quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 5/27/2025.Corrected information: h6.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.

• Brand Name: PRLNE BLU 24IN 6-0 D/A BV-1 EP
• Common Device Name: SUTURES - NON-ABSORBABLE
• 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: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 21909773
• Report Number: 2210968-2025-04519
• Device Sequence Number: 11817680
• Product Code: GAW
• UDI-Device Identifier: 10705031208261
• UDI-Public: (01)10705031208261(17)270731(10)SJBADL
• 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
• Report Date (Section B): 05/27/2025

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: EP8805H
• Device Lot Number: SJBADL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2022
• 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