MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 60IN 0 S/A CTX LP; SUTURE, SURGICAL, ABSORBABLE

Model Number	PDP990G
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that it was immediately found on (b)(6) 2023 that there had been foreign matter in the newly dispensed suture during normal checking by the hospital.The package isn't opened.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).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.Video analysis summary: this is an analysis for a photo and video submitted to ethicon for evaluation.During the visual analysis, the following was observed: the video and photo show a sealed box that pertain to product code pdp990g with a foreign body (hair) inside the sealed box.No conclusion or root cause could be determined.Please refer to the device analysis for full analysis details and conclusion.H3 analysis summary: the product was returned to ethicon inc for evaluation.Visual inspection evaluation was conducted on the returned device.The returned sample determined that it was received, one sealed box that pertain to product code pdp990g.Upon initial inspection of the sample foreign matter (hair) could be observed into the sealed box.Based on the information currently available, the foreign matter was identified during the investigation of the samples received.This product issue will be addressed through ethicon quality system.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 2360 g/m.

• Brand Name: PDS+ VIO 60IN 0 S/A CTX 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; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17052589
• Report Number: 2210968-2023-04038
• Device Sequence Number: 6814527
• Product Code: NEW
• UDI-Device Identifier: 10705031048713
• UDI-Public: 10705031048713
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 11/30/2023
• Device Model Number: PDP990G
• Device Catalogue Number: PDP990G
• Device Lot Number: RPMCMR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2021
• 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