MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 36IN 0 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDP346H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).Date sent to the fda: 12/30/2025.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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: did the reported issue contribute to any patient adverse consequences? no.Could you kindly perform and document the follow-up attempt for the product return? furthermore, please ensure that the shipment tracking number is recorded in the notes or rmao sections.The product sample has not been returned by the customer; as soon as it arrives, it will be sent to j&j.Please provide the source or name of person providing answers to follow-up questions:jft (please refer to the attached email).It is reported that the client notifies that he discarded the samples, so we do not have these to return and be able to carry out the investigation process of the case.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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2025 and suture was used.At the time of using pds plus 0 suture, when removed from the package and removed memory from the suture, the needle thread was detached.A suture of the same type was requested and, when the closure of the wound was almost over, the same happened as in the previous case.By virtue of the above, they kindly request that the respective investigation be conducted into the related report.There were no patient consequences reported.Additional information was requested.

• Brand Name: PDS+ VIO 36IN 0 S/A CT-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• 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: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23926352
• Report Number: 2210968-2025-14699
• Device Sequence Number: 18399501
• Product Code: NEW
• UDI-Device Identifier: 10705031048126
• UDI-Public: (01)10705031048126(17)261130(10)1059MB
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• PMA/510(K) Number: K061037
• 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
• Report Date (Section B): 12/30/2025

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: PDP346H
• Device Lot Number: 1059MB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2024
• 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