MAUDE Adverse Event Report: ETHICON INC. PDS PLUS VIO 8X18IN 1 S/A CTXB CR; SUTURES - ABSORBABLE

Catalog Number	PDPB765D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint number: (b)(4).Component code: (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information was requested, and the following was obtained: please clarify how many needles experienced easy pull off from the suture.Two needles.When the 2nd and the 3rd needle were held, the needles were detached from a suture easily.When the 6th and the 7th needle were held, the needles were detached 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 - (b)(6).Active ingredient(s)- triclosan.Dosage form - suture/solid/parenteral.Strength = 2360 g /m.Related to: 2210968-2021-11033.
Event or Problem Description
It was reported that a patient underwent a low anterior resection procedure on (b)(6) 2021 and suture was used.During the procedure, when the 6th and 7th needles were held, the needles became detached from the suture easily.These were control release needles.Another like device was used to complete the procedure.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 12/16/2021.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.H3 investigational summary: visual analysis of the needle from slot # 3 product code pdpb765 and the swage and attachment area were noted to be as expected, no marks by the surgical instrument were noted on body needle and no suture remnant could be observed into the barrel hole.The suture was not received for evaluation to determine the assignable cause.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.No conclusion could be reached as to what caused the reported complaint.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.Visual analysis of the returned sample revealed that one sample (a tray with eight needles and a dispensed suture), of product code pdpb765, was received to ethicon inc for evaluation.The product is control release and each tray contains eight strands.After investigation of the sample dispensed suture and a needle from slot # 2, short insertion was observed in the strand.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.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 inc¿s quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.Trade name - pds plus antibacterial.Active ingredient(s)- triclosan.Dosage form - suture/solid/parenteral.Strength - = 2360 g /m.

• Brand Name: PDS PLUS VIO 8X18IN 1 S/A CTXB CR
• Common Device Name: SUTURES - 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; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12799468
• Report Number: 2210968-2021-11302
• Device Sequence Number: 4994561
• Product Code: NEW
• UDI-Device Identifier: 10705031218901
• UDI-Public: 10705031218901
• Combination Product (Y/N): N
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2021

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 Expiration Date: 02/28/2023
• Device Catalogue Number: PDPB765D
• Device Lot Number: RCMCHM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2021
• Supplement Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2021
• 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