MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 27IN 3-0 S/A RB-1; SUTURE, SURGICAL, ABSORBABLE

Model Number	PDP305H
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
Product complaint#: (b)(4).Additional information has been requested however and received.If further details are received at a later date a supplemental medwatch will be sent.Correct description : the connection part between the needle and the suture was detached.This happened three times in a row.Were x-rays performed to localize the needle? no further information is available.Was the needle removed from the patient? no further information is available.Procedure name and date? no further information is available.Event date? no further information is available.No further information will be provided.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.No product available for return.Note: events reported on mw# 2210968-2022-05254, mw# 2210968-2022-05255.Trade name - irgacare® active ingredient(s) ¿ triclosan dosage form ¿ suture/solid/parenteral strength ¿ = 2360 g/m all others 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 a patient underwent an unknown surgery on an unknown date and suture was used.During surgery, the suture broke immediately during use.It seemed that the suture detached at the connection part between the needle and the suture.Further details are not provided.No sample will be returned.There were no adverse consequences to the patient.

• Brand Name: PDS+ VIO 27IN 3-0 S/A RB-1
• 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: 14955056
• Report Number: 2210968-2022-05253
• Device Sequence Number: 5485784
• Product Code: NEW
• UDI-Device Identifier: 10705031047983
• UDI-Public: 10705031047983
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/08/2022

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 Expiration Date: 09/30/2023
• Device Model Number: PDP305H
• Device Catalogue Number: PDP305H
• Device Lot Number: RLMKRH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown