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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL, ASD, INC. PORTEX MINI-TRACH II - NON SELDINGER KIT; CRICOTHYROTOMY KIT
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SMITHS MEDICAL, ASD, INC. PORTEX MINI-TRACH II - NON SELDINGER KIT; CRICOTHYROTOMY KIT Back to Search Results
Catalog Number 100/461/000
Device Problem Positioning Failure (1158)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that after indwelling a tuohy needle in a patient, the customer attempted to insert the guidewire into it; but couldn't with the use of a portex® mini-trach® ii - non seldinger kit.No patient injury.
 
Manufacturer Narrative
One tuohy needle and one guide wire were provided for evaluation.The needle was tested and found to be inserted without resistance.The guide wire was tested as well, and upon insertion was not found to have resistance.Every needle received at smiths medical (b)(4) gets inspected randomly and there have been no deviations in the inspection protocol of the involved needle lots.The reported complaint was not confirmed and revealed no intrinsic evidence to suggest a root cause related to manufacturing.
 
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Brand Name
PORTEX MINI-TRACH II - NON SELDINGER KIT
Type of Device
CRICOTHYROTOMY KIT
Manufacturer (Section D)
SMITHS MEDICAL, ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key7396086
MDR Text Key104476606
Report Number3012307300-2018-00663
Device Sequence Number1
Product Code OGP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 11/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/26/2022
Device Catalogue Number100/461/000
Device Lot Number3457249
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/24/2018
Was the Report Sent to FDA? No
Date Manufacturer Received08/09/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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