TRACHEOSTOMY PVC - PORTEX TUBES BLUE LINE ULTRA (BLU) YES JP-03411; US-87519; B/L ULTRA SUCTIONAID 8.0MM 10/CA 100/800/060

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-28 for TRACHEOSTOMY PVC - PORTEX TUBES BLUE LINE ULTRA (BLU) YES JP-03411; US-87519; B/L ULTRA SUCTIONAID 8.0MM 10/CA 100/800/060 manufactured by Smiths Medical Asd,inc.

Event Text Entries

[185482216] Information received a smith medical tracheostomy
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2020-02355
MDR Report Key9895002
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-28
Date of Report2020-03-28
Date of Event2020-02-11
Date Mfgr Received2020-02-28
Device Manufacturer Date2018-12-20
Date Added to Maude2020-03-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactDAVE HALVERSON
Manufacturer Street6000 LANE N
Manufacturer CityMINNEAPOLIS, MN
Manufacturer CountryUS
Manufacturer Phone3833310
Manufacturer G1SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
Manufacturer StreetAVE CALIDAD NO. 4, PARQUE INDUSTRIAL INTERNACIONA
Manufacturer CityTIJUANA, B.C. 22425
Manufacturer CountryMX
Manufacturer Postal Code22425
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTRACHEOSTOMY PVC - PORTEX TUBES BLUE LINE ULTRA (BLU) YES JP-03411; US-87519;
Generic NameTRACHEOSTOMY AND TUBE CUFF
Product CodeJOH
Date Received2020-03-28
Returned To Mfg2020-03-06
Model NumberB/L ULTRA SUCTIONAID 8.0MM 10/CA
Catalog Number100/800/060
Lot Number3702846
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD,INC
Manufacturer Address6000 LANE N MINNEAPOLIS, MN US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2020-03-28

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