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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR) PRODUCT CODE: BTO
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SMITHS MEDICAL ASD, INC. BIVONA UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR) PRODUCT CODE: BTO Back to Search Results
Catalog Number 60SP040JJP
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/12/2020
Event Type  malfunction  
Manufacturer Narrative
Foreign report source: (b)(6).
 
Event Description
Information was received that during the use of a smiths medical bivona uncuffed neonatal and pediatric tracheostomy tube, the flange got torn.No patient injury.
 
Manufacturer Narrative
Device evaluation: returned device was received with the flange broken.During the evaluation of the device the customer reported condition was confirmed.Problem source is unknown.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
 
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Brand Name
BIVONA UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE
Type of Device
TUBE, TRACHEOSTOMY (W/WO CONNECTOR) PRODUCT CODE: BTO
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis, mn
MDR Report Key9951945
MDR Text Key187378509
Report Number3012307300-2020-02891
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 05/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number60SP040JJP
Device Lot Number3579314
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/19/2020
Date Manufacturer Received04/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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