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

Catalog Number 100/382/118CZ

Device Problem Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Device expiration and manufacture dates could not be determined with information provided.

Event Description

It was reported that the physician was facing a problem with an epidural block while using a portex® epidural catheter.Physician checked catheter with the epifus connector before using on the patient.However, the drug did not deliver at other end of the catheter.No patient injury was associated with this occurrence.

• Brand Name: PORTEX® EPIDURAL CATHETER
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL, ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL CZECH REPUBLIC; olomoucka 306; hranice, 753 0 1; EZ 753 01
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7558024
• MDR Text Key: 109756717
• Report Number: 3012307300-2018-02022
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/382/118CZ
• Device Lot Number: 2994454
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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