MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC.; ANESTHESIA, CONDUCTION KIT

Device Problems Break (1069); Device Damaged Prior to Use (2284)

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

Event Type  malfunction  

Manufacturer Narrative

A product sample was received for investigation.Visual and functional testing of the retuned sample was checked with the applicable go-pin (1,12mm) and no-go-pin (1,22mm).No deviations were detected during this test.Based on the investigation results, it is likely that this incident is not due to a product failure of the tuohy needle.The exact root cause for this incident could not be determined definitely from the provided information.No corrective or preventive action will be taken at this time.A device history record review of the included epidural needle could not be performed, as no lot number of the affected finished good was provided.No product information has been provided to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).

Event Description

It was reported that the epidural needles and catheters were faulty.No patient injury was reported.

• 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; minneapolis, MN 55442
• MDR Report Key: 15315074
• MDR Text Key: 305386893
• Report Number: 3012307300-2022-16571
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/09/2022
• 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