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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX TUBES BLUE LINE; TRACHEOSTOMY TUBE
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SMITHS MEDICAL ASD, INC. PORTEX TUBES BLUE LINE; TRACHEOSTOMY TUBE Back to Search Results
Model Number 100/515/070
Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/01/2020
Event Type  malfunction  
Event Description
It was reported that a smiths medical portex tubes blue line had a leak after a patient was transferred from another facility intubated.No adverse patient effects were reported.
 
Event Description
Investigation completed and summarized in h 10.
 
Manufacturer Narrative
Other, other text: investigation completed on a smiths tracheostomy|pvc - portex tubes blue line classic four pictures received with revealed small tear in cuff.Samples received by shm investigation: one (1) used sample was returned for evaluation p/n 100/515/070 with lot number reported unknown; the sample was received in used conditions without its original packaging.During functional testing submerging under water, which reveled burble coming out of the small tear.A review was looked at the dhr and other engineering.
 
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Brand Name
PORTEX TUBES BLUE LINE
Type of Device
TRACHEOSTOMY TUBE
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key10767648
MDR Text Key214087148
Report Number3012307300-2020-10893
Device Sequence Number1
Product Code BTO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number100/515/070
Device Catalogue Number100/515/070
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/02/2020
Was the Report Sent to FDA? No
Date Manufacturer Received11/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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