MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 18IN 5-0 S/A TF; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	D6713
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2023 and suture was used.Before use on the patient, the sales rep reported that the customer received there box of sutures but on the box it shows its an rb needle but it is supposed to be a tf needle.No patient usage.No adverse patient consequences were reported.Additional information was requested.
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.H3 device analysis: the product was returned for evaluation.Visual inspection was conducted on the returned device.The returned sample revealed that it was received, two sealed boxes that pertained to product code d6713.During the evaluation of the returned samples, it was noted that the needle sales type print on the boxes is rb-2 and all foils were noted with the needle sales type of rb-2.After further investigation, it was found that new multisuture non-ce marked products were created under project vantage, which consists of needle rmc changes (needle-making site, hole size, coating, etc.) and standardized graphics for box, sleeve, and primary (folder, tray lid & foil).This change impacted the product code d6713.In addition, the two sale types were reviewed in the system and the needle characteristics for ft and rb-2 are the same.Both needles belong to a curvature 1/2 circle, taper point, 13 mm.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.Due to a change in the needle, the event described could not be confirmed.Although no product defect was identified.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Brand Name: PDSII VIO 18IN 5-0 S/A TF
• 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: 17755052
• Report Number: 2210968-2023-06742
• Device Sequence Number: 6664992
• Product Code: NEW
• UDI-Device Identifier: 10705031026698
• UDI-Public: 10705031026698
• 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
• Report Date (Section B): 09/15/2023

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: D6713
• Device Lot Number: SPMCRM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2022
• 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