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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL PORTEX; TRACHEOSTOMY

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ST PAUL PORTEX; TRACHEOSTOMY Back to Search Results
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/24/2020
Event Type  Injury  
Event Description
Information received a smiths medical bivona tracheostomy tube flange split on the bivona tube.The 1st time was noted on (b)(6) 2020 and the 2nd time was on (b)(6) 2020.Both times tube changes were done successfully with no harm to the young person.
 
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Brand Name
PORTEX
Type of Device
TRACHEOSTOMY
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key10971611
MDR Text Key220399623
Report Number3012307300-2020-12221
Device Sequence Number1
Product Code JOH
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation Nurse
Type of Report Initial
Report Date 12/08/2020
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
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/09/2020
Initial Date FDA Received12/08/2020
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 Number1
Patient Outcome(s) Required Intervention;
Patient Age9 YR
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