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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
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NULL BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC; TUBE, TRACHEOSTOMY (W/WO CONNECTOR) Back to Search Results
Device Problem Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/28/2022
Event Type  Injury  
Event Description
It was reported that while assisting with a routine tracheostomy tube change for a patient, (bivona flextend 5.0mm tube) the tube being placed was on it's fourth usage.When the tube was placed into the patient's stoma the introducer became stuck, attempted to remove it unsuccessfully.This resulted in an emergency tube which was traumatic for the patient.
 
Event Description
It was reported that while assisting with a routine tracheostomy tube change for a patient, (bivona flextend 5.0mm tube) the tube being placed was on it's fourth usage.When the tube was placed into the patient's stoma the introducer became stuck, attempted to remove it unsuccessfully.This resulted in an emergency tube which was traumatic for the patient.
 
Manufacturer Narrative
Other, other text: b5: additional information received 08-mar-2022: product and packing was not retained.Item and lot numbers are not known.- product will not be returned for investigation.H6: event problem and evaluation codes: updated.H10: device evaluation: no product was returned.We are unable to confirm the reported complaint.If the product is returned, smiths medical will reopen this complaint for further investigation.
 
Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.
 
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Brand Name
BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC
Type of Device
TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
Manufacturer (Section G)
NULL
MDR Report Key13600949
MDR Text Key286148995
Report Number3012307300-2022-04156
Device Sequence Number1
Product Code BTO
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 04/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/21/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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