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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX TRACHEOSTOMY REPLACEMENT INNER CANNULA; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
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SMITHS MEDICAL ASD, INC. PORTEX TRACHEOSTOMY REPLACEMENT INNER CANNULA; TUBE, TRACHEOSTOMY (W/WO CONNECTOR) Back to Search Results
Model Number 526070
Medical Device Problem Codes Accessory Incompatible (1004); Connection Problem (2900)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/11/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).
 
Event or Problem Description
Information was received that a smiths medical portex tracheostomy replacement inner cannula would not clip into the patient's tracheostomy tube as the snap was not holding.There were no adverse patient effects.
 
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Brand Name
PORTEX TRACHEOSTOMY REPLACEMENT INNER CANNULA
Common Device Name
TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key8528644
Report Number3012307300-2019-02114
Device Sequence Number1884413
Product Code BTO
UDI-Device Identifier10351688041135
UDI-Public10351688041135
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K903730
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 04/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Expiration Date12/04/2023
Device Model Number526070
Device Catalogue Number526070
Device Lot Number3739646
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/21/2019
Initial Report FDA Received Date04/18/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
SMITHS MEDICAL PORTEX TRACHEOSTOMY TUBE
Patient Age3 MO
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