PORTEX BIVONA TRACHEOSTOMY TUBE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-19 for PORTEX BIVONA TRACHEOSTOMY TUBE manufactured by Smiths Medical Asd; Inc..

Event Text Entries

[184264131] The available information from the customer does not indicate as to which patient expired nor does it state which tracheostomy tubes are related to which patient. It was reported that the leak or tear were new issues that occurred as both patients had been at the hospice facility for several months with no issues. The following five complaints have been submitted and are all related. 3012307300-2020-02139-0067798. 3012307300-2020-02140-0067800. 3012307300-2020-02141-0067801. 3012307300-2020-02142-0067802. 3012307300-2020-02143-0067803.
Patient Sequence No: 1, Text Type: N, H10


[184264132] Information was received on two separate patients, indicating that 24-48 hours following placement of a smiths medical portex bivona tracheostomy tube, was found to be compromised. It was reported that trach was changed out until the issue was resolved. Both patients were noted to be ventilator dependent, on hospice and receiving high pressures from the ventilator. Unfortunately, one patient later expired. It was reported that the patient death was not related to the trach tube. Patient one: received two trach tube change outs 24-48 hours following placement with a cuff tear of pin-hole cuff leak noted. Patient two: received three trach tube change outs 24-48 hours following placement with a cuff tear of pin-hole cuff leak noted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2020-02139
MDR Report Key9857791
Report SourceUSER FACILITY
Date Received2020-03-19
Date of Report2020-03-19
Date Mfgr Received2020-02-19
Date Added to Maude2020-03-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactDAVE HALVERSON
Manufacturer Street6000 NATHAN LANE N
Manufacturer CityMINNEAPOLIS,, MN
Manufacturer CountryUS
Manufacturer Phone3833310
Manufacturer G1SMITHS MEDICAL INTERNATIONAL LTD.
Manufacturer StreetBOUNDARY ROAD
Manufacturer CityHYTHE, KENT CT216JL
Manufacturer CountryUK
Manufacturer Postal CodeCT21 6JL
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePORTEX BIVONA TRACHEOSTOMY TUBE
Generic NameTUBE TRACHEOSTOMY AND TUBE CUFF
Product CodeJOH
Date Received2020-03-19
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD; INC.
Manufacturer Address6000 NATHAN LANE N MINNEAPOLIS,, MN US


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Required No Informationntervention 2020-03-19

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