MAUDE Adverse Event Report: ETHICON INC. PDS PLUS VIO 96IN 1 S/A TP-1 LP; SUTURE, SURGICAL, ABSORBABLE

Model Number	PDP880G
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint number: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, and the following was obtained: was the integrity of the seal compromised? i don¿t know what you mean did the packaging look damaged? the package looked inflated.Could you confirm if the suture packing inflated and anomalies are present in this packing 12 times on the same patient? or did it occur on different occasions? i can¿t confirm.Did the event occur during one or multiple patient procedures? during revision in pharmacy.What is the total number of procedures? if this event occurred in multiple procedures, please create a product complaint for each event and provide the respective reference number(s).No pocedures.The product is in the institution.Are any samples available of evaluation? yes, next week i can deliver it.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.
Event or Problem Description
During revision in the pharmacy the suture packing is inflated and anomalies are present in this packing in relation to the usual product.There were no patient consequences reported.Additional information was requested.

• Brand Name: PDS PLUS VIO 96IN 1 S/A TP-1 LP
• 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; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15108680
• Report Number: 2210968-2022-05953
• Device Sequence Number: 19871066
• Product Code: NEW
• UDI-Device Identifier: 10705031048669
• UDI-Public: 10705031048669
• Combination Product (Y/N): Y
• Initial Reporter Country: AR
• 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
• Report Date (Section B): 07/26/2022

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: 01/31/2024
• Device Model Number: PDP880G
• Device Catalogue Number: PDP880G
• Device Lot Number: SBMBJS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2022
• Initial Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2022
• 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