TUBE TRACHEOSTOMY AND TUBE CUFF

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 2020-03-25 for TUBE TRACHEOSTOMY AND TUBE CUFF manufactured by Smiths Medical Asd,inc..

Event Text Entries

[184995768] No product to be returned. The product was packaged (b)(6) 2019 on alloyd 2. Dhr's review found no discrepancies or anomalies relevant to the complaint. In-process, product was inspected for leakage and no non-conformities were noted. Incoming records review for cuff component cp370 (lot # 3859259) found no issues relevant to the complaint.
Patient Sequence No: 1, Text Type: N, H10


[184995769] Information received a smith medical tracheostomy reports cuff is failing and damaged. The reporter stated third tach to have same issue. Unknown what brand. The event reported this occurred immediately upon use. No reported adverse events to patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2020-02238
MDR Report Key9881210
Report SourceUSER FACILITY
Date Received2020-03-25
Date of Report2020-03-25
Date of Event2020-02-25
Date Mfgr Received2020-02-25
Date Added to Maude2020-03-25
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 MEDICAL ASD,INC
Manufacturer Street6000 LANE N
Manufacturer CityMINNEAPOLIS, MN
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTUBE TRACHEOSTOMY AND TUBE CUFF
Generic NameTUBE TRACHEOSTOMY AND TUBE CUFF
Product CodeJOH
Date Received2020-03-25
Model NumberTRACHEOSTOMY
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD,INC.
Manufacturer Address6000 NATHAN LANE NORTH MINNEAPOLIS, MN US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-25

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