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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF
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SMITHS MEDICAL ASD, INC. BIVONA TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF Back to Search Results
Catalog Number 60SP035
Medical Device Problem Code Defective Component (2292)
Health Effect - Clinical Codes No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event 07/01/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(6).One trach tube was returned for analysis.Visual inspection performed and product found to be in broken as described by the customer.Customer's complaint was verified.As a preventive action production personnel was notified by area trainer of the defect reported by the customer.The problem source is damage that occurred after shipment to the customer.
 
Event or Problem Description
Information was received that the bivona tracheostomy tube had a broken obturator in the package.No reported adverse effects.
 
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Brand Name
BIVONA TRACHEOSTOMY TUBES
Common Device Name
TUBE TRACHEOSTOMY AND TUBE CUFF
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key7944711
Report Number3012307300-2018-03987
Device Sequence Number2338226
Product Code JOH
UDI-Device Identifier15021312000375
UDI-Public15021312000375
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K912469
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/08/2018
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 Number60SP035
Device Lot Number3489379
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/27/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/31/2018
Initial Report FDA Received Date10/08/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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