MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 8X18IN 1 S/A CTB CR; SUTURE, SURGICAL, ABSORBABLE

Model Number	PDPB751D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.The following information was requested, but unavailable: when was the suture was detached from the needle easily (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? a manufacturing record evaluation was performed for the finished device lot and no non-conformances were identified.This is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name - irgacare®, active ingredient(s) ¿ triclosan, dosage form ¿ suture/solid/parenteral, strength ¿ = 2360 g/m.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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.The suture was detached from the needle easily.It was a control release needle.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 2/28/2023.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.H6 component code: g07002 no device problem found: h3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that it was received one empty foil, three used needles, one winding former with five needle-suture combinations that pertain to product code pdpb751d.This product is control release and required eight strands per packet.Overall, the returned sample shows that three needles were used.These needles were examined, and the swage and attachment area were noted to be as expected.The barrel hole was examined under magnification, and none was observed.In the visual inspection of five-needle suture combinations, the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no anomalies were observed during the evaluation.The functional test was performed, and the pull force result met the requirements.As part of the ethicon 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.

• Brand Name: PDS+ VIO 8X18IN 1 S/A CTB CR
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16244830
• Report Number: 2210968-2023-00529
• Device Sequence Number: 6400641
• Product Code: NEW
• UDI-Device Identifier: 10705031218871
• UDI-Public: 10705031218871
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2023

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: 06/30/2024
• Device Model Number: PDPB751D
• Device Catalogue Number: PDPB751D
• Device Lot Number: SHMDPJ
• 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: 01/10/2023
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 01/25/2023
• Supplement Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2022
• 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