MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 8X18IN 3-0 S/A SH CR; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z774D
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown ob-gyn procedure on (b)(6) 2022 and suture was used.When opening the package, it was found that there was j774d in the package not z774d.The actual product was discarded.There were no adverse consequences to the patient.No further information was provided.
Additional Manufacturer Narrative
(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.Attempts are being made to retrieve the device sample.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.(b)(4).
Additional Manufacturer Narrative
(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.Additional information: d9, h3, h4, h6.H3 analysis summary: the product was returned to ethicon for evaluation.Visual inspection evaluation was conducted on the returned device.Visual analysis of the returned sample revealed that one empty opened foil that pertains to product code z774d, lot sdmqrp and one paper lid that pertains to product code j774d were returned for analysis.In order to evaluate the conditions of the returned sample, the foil of product code z774d was received completely open and empty.No product for j774d was received.For this reason, it was not possible to determine if there was j774d in the package z774d.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.It should be noted that as part of our quality process, the device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.No conclusion could be reached as to what caused the reported complaint.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.

• Brand Name: PDSII VIO 8X18IN 3-0 S/A SH CR
• 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: 15759001
• Report Number: 2210968-2022-09268
• Device Sequence Number: 8245349
• Product Code: NEW
• UDI-Device Identifier: 10705031061736
• UDI-Public: 10705031061736
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N18331
• 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,Followup
• Report Date (Section B): 11/09/2022

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: Z774D
• Device Catalogue Number: Z774D
• Device Lot Number: SDMQRP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2022
• Supplement Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2022
• 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