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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BIVONA® AIRE-CUF® PEDIATRIC TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF
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SMITHS MEDICAL ASD, INC. PORTEX® BIVONA® AIRE-CUF® PEDIATRIC TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF Back to Search Results
Catalog Number 65SP035
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/11/2017
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that a break was found in the flange of a portex® bivona® aire-cuf® pediatric tracheostomy tube.No injury was reported.
 
Additional Manufacturer Narrative
One device was returned for evaluation in used condition.Visual inspection found that the device had a split on the flange eyelet.A review of the testing and inspection documents was performed and deemed adequate and correct.A review of the manufacturing process was performed on a similar part and found no discrepancies.Based on the evidence, a root cause was unable to be determined.
 
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Brand Name
PORTEX® BIVONA® AIRE-CUF® PEDIATRIC TRACHEOSTOMY TUBE
Common Device Name
TUBE TRACHEOSTOMY AND TUBE CUFF
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key6770911
Report Number3012307300-2017-01704
Device Sequence Number881529
Product Code JOH
UDI-Device Identifier15021312000290
UDI-Public15021312000290
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K083641
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,user facility
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 04/11/2018
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 Health Professional
Device Catalogue Number65SP035
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/21/2017
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/19/2017
Supplement Date Received by Manufacturer03/15/2018
Initial Report FDA Received Date08/07/2017
Supplement Report FDA Received Date04/11/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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