MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX GENERAL ANESTHESIA KIT; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number NSE4200FCJP

Device Problem Material Separation (1562)

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

Event Date 06/01/2022

Event Type  malfunction  

Manufacturer Narrative

No lot number was provided; therefore, device history record review could not be performed.A product sample was received for evaluation.Visual inspection was performed.Visual inspection found was confirmed that it was broken at a point 14 cm from the tip on the patient side.The catheter showed almost no elongation.When the fracture surface was observed with a microscope, it was confirmed that the cross section was sharp and crushed in an elliptical shape, which closely resembled the trace of fracture between sharp blades such as scissors.The root cause of the reported issue was found to be user interface.

Event Description

It was reported that during the use of the product with a pump, the epidural catheter got torn off.No patient injury was reported.

• Brand Name: PORTEX GENERAL ANESTHESIA KIT
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 2-12-12, kitanagase-omotemachi; minneapolis, MN 55442
• MDR Report Key: 15089414
• MDR Text Key: 304346829
• Report Number: 3012307300-2022-14021
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NSE4200FCJP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1