MAUDE Adverse Event Report: ETHICON INC. PDS PLUS VIO 8X18IN(45CM) USP4-0(M1.5) S/A RB-1 CR; SUTURES - ABSORBABLE

Catalog Number	PDP712D
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4) h3 investigation summary: the product was returned to ethicon for evaluation.One winding former with eight needle suture combinations and one open foil were received for analysis.The product code pdp712d is multistrand and contains eight strands per packet.During analysis of foil, it was noted that the foil packet was received previously open additionally, wrinkles and a hole in the cavity were identified.The seal area was inspected, and evidence of proper sealing was confirmed.The condition of the package is indicative of handling and storage issues that occurred outside of ethicon control.Furthermore, the needle suture combinations were dispensed, and no anomalies were observed during the evaluation.To complement this assessment, a photo was provided showing one labeled winding former with needle suture combinations and one foil packet that pertains to product code pdp712d inside the plastic bag.As part of the quality process all devices are manufactured, inspected, and released to approved specifications.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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2025 and suture was used.Before use on the patient, it was reported that the seal was found untight when it was opened to prepare for surgery.The customer suspected that the seal of the package isn't tight.No additional information could be provided.There were no adverse consequences reported.Additional information was requested.

• Brand Name: PDS PLUS VIO 8X18IN(45CM) USP4-0(M1.5) S/A RB-1 CR
• Common Device Name: SUTURES - 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: 22680700
• Report Number: 2210968-2025-08909
• Device Sequence Number: 9663730
• Product Code: NEW
• UDI-Device Identifier: 10705031218758
• UDI-Public: (01)10705031218758(17)290831(10)103CQZ
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/31/2025

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: PDP712D
• Device Lot Number: 103CQZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2024
• 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