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

Model Number	PDP334H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a unknown procedure on an unknown date and suture was used.During the procedure, the suture became detached from the needle.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint number: (b)(4).(b)(4).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: please provide answers to the following questions in relation to this product complaint.Was the needle removed from the patient? was there any patient consequence or injury? was the procedure completed successfully? procedure name and date? event date? lot number? please note we are yet to receive the tracking details for (b)(4).Please also provide us with an update with regards to the product return.Have you already returned the product for analysis? (if yes, please confirm the date shipped and the courier tracking number) if the hospital has not or will not release the product until a future date please confirm this and what the future date is.If the product is no longer available please advise.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 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.

• Brand Name: PDS+ VIO 27IN 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
• MDR Report Key: 14545280
• Report Number: 2210968-2022-04126
• Device Sequence Number: 6774614
• Product Code: NEW
• UDI-Device Identifier: 10705031048072
• UDI-Public: 10705031048072
• Combination Product (Y/N): Y
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/30/2022

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: PDP334H
• Device Catalogue Number: PDP334H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 05/30/2022
• 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