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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL BIVONA TUBES; TRACHEOSTOMY
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ST PAUL BIVONA TUBES; 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 08/05/2020
Event Type  malfunction  
Event Description
Information received a smiths medical tracheostomy|silicone - bivona tubes custom malfunctioned, as eyelet tore and was unable to hold ties for a custom trach.Photo was attached.No patient adverse events reported.
 
Manufacturer Narrative
Other, evaluation results: one custom bivona tracheostomy tube was returned for investigation in used condition.The investigation determined that the eyelet was nicked/cut, which propagated into a tear.The instructions for use advise to guard against product damage by avoiding contact with sharp edges.Some tracheostomy tube holders contain velcro or metal clips which may have sharp edges.These sharp edges can come into contact with the eyelets and compromise the product integrity.While the product complaint (torn eyelet) was confirmed, a definitive root cause was not established.
 
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Brand Name
BIVONA TUBES
Type of Device
TRACHEOSTOMY
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key10482118
MDR Text Key205279336
Report Number3012307300-2020-08942
Device Sequence Number1
Product Code JOH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 10/07/2020
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 No Information
Was Device Available for Evaluation? No
Date Returned to Manufacturer08/07/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/05/2020
Initial Date FDA Received09/02/2020
Supplement Dates Manufacturer Received09/15/2020
Supplement Dates FDA Received10/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age7 YR
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