MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 27IN 2-0 S/A CT-2; SUTURE, SURGICAL, ABSORBABLE

Model Number	PDP333H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.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.Device analysis: the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that one empty labeled winding former, one detached needle and a suture of product code pdp333h were received for evaluation.After investigation of the sample short insertion was observed in the strand, and the visual inspection concluded that the combination of the needle/suture was found detached since the insertion end of the suture did not meet the requirement, this defect is caused because the suture was not correctly inserted inside of the needle barrel hole resulting in a pull-out defect.Based on the information currently available, the pull-out was identified during the investigation of the sample received.This product issue will be addressed through ethicon quality system.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ 2360 g/m.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2022 and suture was used.During the procedure, the needle just fell off the suture material when opened from the packaging and loaded onto the needle holder.Opened another suture to continue with the procedure.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that one empty labeled winding former, one detached needle and a suture of product code pdp333h were received for evaluation.After investigation of the sample short insertion was observed in the strand, and the visual inspection concluded that the combination of the needle/suture was found detached since the insertion end of the suture did not meet the requirement, this defect is caused because the suture was not correctly inserted inside of the needle barrel hole resulting in a pull-out defect.No adverse patient consequences were reported.

• Brand Name: PDS+ VIO 27IN 2-0 S/A CT-2
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15289590
• Report Number: 2210968-2022-06905
• Device Sequence Number: 2504591
• Product Code: NEW
• UDI-Device Identifier: 10705031048065
• UDI-Public: 10705031048065
• Combination Product (Y/N): Y
• Initial Reporter Country: NZ
• 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): 08/24/2022

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 Model Number: PDP333H
• Device Catalogue Number: PDP333H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2022
• Initial Report FDA Received Date: 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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