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

Catalog Number 100/391/116CZ

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2019

Event Type  malfunction  

Event Description

It was reported that the catheter broke during removal.The incident occurred during induction.The clinician attempted an alternate space, however the desired length of the catheter could not be inserted.The clinician abandoned the procedure as a result.No patient injury or further complications were reported in relation to this event.Additional information was requested inquiring about whether or not the catheter broke off in the patient, and what medical interventions (if any) were taken.Information pertaining to the health outcome of the patient was also requested.This additional information has not yet been received.Should additional relevant information be received, a supplemental report will be submitted.

• Brand Name: PORTEX
• 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 A. S.; olomoucka 306; hranice 1 - mesto; hranice, 75301 ; EZ 75301
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 8912635
• MDR Text Key: 162032081
• Report Number: 3012307300-2019-04208
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2021
• Device Catalogue Number: 100/391/116CZ
• Device Lot Number: 3138613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1