MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 30IN 6-0 D/A RB-2; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z149H
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a kidney transplant procedure on (b)(6)2024 and suture was used.During the procedure, it was reported by the sales rep who was in the case that during a kidney transplant procedure that surgeon opened two packs of suture and felt that the wrong needle was on the suture.A third pack was opened to continue with the procedure.No device returning.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4) h6 component code: g07002 - device not returned 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.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.D4: udi: the manufacture and expiration dates are currently not available.Therefore, the full udi is currently not available.
Additional Manufacturer Narrative
Product complaint #(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, and no non-conformances were identified.

• Brand Name: PDSII VIO 30IN 6-0 D/A RB-2
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20833974
• Report Number: 2210968-2024-12760
• Device Sequence Number: 18359133
• Product Code: NEW
• UDI-Device Identifier: 10705031060289
• UDI-Public: (01)10705031060289(17)290531(10)101XAZ
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2025

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 Catalogue Number: Z149H
• Device Lot Number: 101XAZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2024
• 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