MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 30IN 5-0 D/A C-1; SUTURE, SURGICAL, ABSORBABLE

Model Number	PDP126H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
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.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.Additional information was requested and the following was obtained: please provide procedure name and date.Pancreas surgery, anastomosis; date is unknown.Please provide lot number: unknown.How was procedure successfully completed? yes.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 a pancreas anastomosis procedure on an unknown date in 2021 and suture was used.During the procedure, the suture and needle detached easily.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PDS+ VIO 30IN 5-0 D/A C-1
• 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
• MDR Report Key: 13044082
• Report Number: 2210968-2021-12758
• Device Sequence Number: 14808482
• Product Code: NEW
• UDI-Device Identifier: 10705031047891
• UDI-Public: 10705031047891
• Combination Product (Y/N): Y
• Initial Reporter Country: TW
• 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
• Report Date (Section B): 12/20/2021

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: PDP126H
• Device Catalogue Number: PDP126H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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