MAUDE Adverse Event Report: ETHICON INC. PDS; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDP468H
Medical Device Problem Codes	Use of Device Problem (1670); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.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.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.It was reported that "during the procedure, the physician requested a tapering suture.However, the suture provided was not a tapering suture and was found to be expired" * product code pdp468h is a reverse-cutting needle.Could you confirm whether a taper-point needle was ordered and a reverse-cutting needle was received in error? * was the expired product used on the patient? were there any patient consequences? * is this device available for analysis? if yes, to whom should the shipper kit be sent? (please provide contact name, department, street address including zip, no po box please, email address, and phone number) * please provide the source or name and title of external person providing answers to follow-up.
Event or Problem Description
It was reported that an animal underwent an unknown veterinary procedure in (b)(6) 2026 and suture was used.During the procedure, it was reported by the account contact that during the procedure, the physician requested a tapering suture.However, the suture provided was not a tapering suture and was found to be expired.No patient consequences were reported.Device returning.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 5/4/2026 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.The following information was requested: our analysis lab received the return kit associated with tracking number (b)(6); however, the kit was received empty.- confirm whether the device is available for return.- advise to whom the shipper kit should be sent and provide the following details: contact name, department, street address (including zip code), email address, and phone number.Please do not use a p.O.Box.- provide the current status of the device(s), as no device has been received for analysis.If the device has already been shipped, please include the shipment tracking details.- provide the source, name, and title of the external person supplying responses to the follow up questions (i.E., the external individual providing information to the sales representative).

• Brand Name: PDS
• 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: 24932293
• Report Number: 2210968-2026-04260
• Device Sequence Number: 10668252
• Product Code: NEW
• UDI-Device Identifier: 10705031048379
• UDI-Public: (01)10705031048379(17)250131(10)TBMMMJ
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/29/2026

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 Expiration Date: 01/31/2025
• Device Catalogue Number: PDP468H
• Device Lot Number: TBMMMJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Supplement Date Received by Manufacturer: 04/21/2026; 05/29/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 05/04/2026; 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2023
• 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