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

Lot Number 201026

Device Problem Defective Device (2588)

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

Event Date 12/10/2020

Event Type  malfunction  

Event Description

It was reported that the customer indwelled the epidural catheter in the patient for the purpose of pain management.The anesthesiology doctor noticed the catheter tip was partially deformed.No patient injury was reported.

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.One epidural catheter sample was received for evaluation.Visual and functional testing were performed.Visual inspection found no abnormality was found in the tip hole, but kink was confirmed in two places in the middle of the catheter (11 cm and 27 cm from the connector side).Functional testing found when water was injected with the syringe, the water discharged from the three tip holes.The root cause of the issue could not be determined.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken.Brand name udi and pma/510 are unknown.No information has been received to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• 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; 3-21-2 motohama-cho, naka-ku,; minneapolis, MN 55442
• MDR Report Key: 15349053
• MDR Text Key: 303418846
• Report Number: 3012307300-2022-17500
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: 201026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/25/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2022
• 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
• Patient Outcome(s): Required Intervention