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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX ENDOBRONCHIAL TUBE; TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)
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SMITHS MEDICAL ASD, INC. PORTEX ENDOBRONCHIAL TUBE; TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR) Back to Search Results
Model Number 198-32L
Medical Device Problem Codes Material Too Rigid or Stiff (1544); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Foreign - report source: (b)(6).(b)(6).
 
Event or Problem Description
Information was received that a smiths medical portex endobronchial tube was in use with a patient at the hospital.The patient was reported to have an unspecified pleural effusion and immediately upon placement had difficulty handling and passing the tube due to its curvature and noted "harder material".Subsequently, another tube of the same brand was used.The patient had no complications.
 
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Brand Name
PORTEX ENDOBRONCHIAL TUBE
Common Device Name
TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key9655278
Report Number3012307300-2020-00649
Device Sequence Number2860514
Product Code CBI
UDI-Device Identifier15019315058608
UDI-Public15019315058608
Combination Product (Y/N)N
Initial Reporter CountryCO
PMA/510(K) Number
K953483
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign,user faci
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 01/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date06/26/2021
Device Model Number198-32L
Device Catalogue Number198-32L
Device Lot Number3666497
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/02/2020
Initial Report FDA Received Date01/31/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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