MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ UNI VIO 18IN 0 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE

Model Number SXPP1A401

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/30/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint number: (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.An image was received for evaluation and it was determined that foreign matter could be observed which appears to be in the product code needle body.Sxpp1a401.The image is not clear enough to determine what kind of foreign matter is present.No conclusion could be reached as to the cause of the reported complaint.It should be noted that as part of our quality process, the device is visually inspected and functionally tested during manufacturing to ensure it meets required specifications prior to shipment.As part of our quality process, manufacturing records were reviewed for this lot's serial number and manufacturing standards were met prior to the release of this lot.Complaint information will continue to be tracked for potential safety signals through complaint trends as part of post-market surveillance.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 Description

It was reported that a patient underwent a myomectomy on (b)(6) 2021.It was reported that there had been unknown foreign matter on the needle tip when the package was opened for sewing the uterus in the surgery.Another like device was used to complete the procedure.There were no patient consequences reported.

• Brand Name: SFX SYM PDS+ UNI VIO 18IN 0 S/A CT-1
• Type of Device: 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
• MDR Report Key: 13420229
• MDR Text Key: 285229014
• Report Number: 2210968-2022-00787
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031219342
• UDI-Public: 10705031219342
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K113004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: SXPP1A401
• Device Catalogue Number: SXPP1A401
• Device Lot Number: RCMLLR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/06/2022
• Date Device Manufactured: 03/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Female