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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA CUSTOM 6.5 U/C STANDARD TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF
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SMITHS MEDICAL ASD, INC. BIVONA CUSTOM 6.5 U/C STANDARD TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF Back to Search Results
Model Number SU14KN65NSC013S
Medical Device Problem Code Contamination (1120)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/24/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(6).
 
Event or Problem Description
Information was received that a smiths medical (b)(6) custom 6.5 u/c standard tracheostomy tube was in use with a patient at the hospital.The reporter stated the device "appeared to be moldy".Subsequently, a tube change out was required.There were no adverse patient effects.
 
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Brand Name
BIVONA CUSTOM 6.5 U/C STANDARD 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 Key9211176
Report Number3012307300-2019-05611
Device Sequence Number19570801
Product Code JOH
UDI-Device Identifier10351688846914
UDI-Public10351688846914
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K944178
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 10/18/2019
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 Model NumberSU14KN65NSC013S
Device Catalogue NumberSU14KN65NSC013S
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/02/2019
Initial Report FDA Received Date10/18/2019
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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