MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX CONTINUOUS EPIDURAL ANESTHESIA TRAY; ANESTHESIA, CONDUCTION KIT

Device Problem Break (1069)

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

Event Date 10/01/2020

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 testing was performed.Visual inspection found no abnormalities such as elongation were found in the catheter, but it was confirmed that the catheter was cut diagonally near the 8 cm marker.No abnormalities such as deformation or breakage were found in the epidural needle.The root cause of the reported issue was found to be manufacturing.We will notify overseas manufacturers of this event and record this event in a database to monitor the future occurrence status.No information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.

Event Description

It was reported that when passing the catheter through into the epidural needle, the customer felt the catheter got torn off on the halfway.After that, he checked the catheter and noticed it was cut off at a point approximately 7 to 8 cm away from its tip.No patient injury was reported.

• Brand Name: PORTEX CONTINUOUS EPIDURAL ANESTHESIA TRAY
• Type of Device: ANESTHESIA, CONDUCTION KIT
• 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; akasaka, minato-ku, tokyo; minneapolis, MN 55442
• MDR Report Key: 15330158
• MDR Text Key: 305376538
• Report Number: 3012307300-2022-17111
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K781052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2022
• 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