SMITHS MEDICAL DELTEC IMPLANTABLE PORTS 21-4155-24

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-02-21 for SMITHS MEDICAL DELTEC IMPLANTABLE PORTS 21-4155-24 manufactured by Smiths Medical Asd, Inc..

Event Text Entries

[180791371] Information was received that upon administration of chemotherapy through a smiths medical deltec implantable port, filtration and extravasation occurred. A peripheral route was installed as a result to administer pending chemotherapy treatment.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2020-01538
MDR Report Key9740028
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2020-02-21
Date of Report2020-02-21
Date Mfgr Received2020-01-22
Device Manufacturer Date2019-01-16
Date Added to Maude2020-02-21
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 NATHAN LANE N
Manufacturer CityMINNEAPOLIS, MN
Manufacturer CountryUS
Manufacturer G1SMITHS MEDICAL ASD, INC.
Manufacturer Street3350 GRANADA AVENUE NORTH SUITE 100
Manufacturer CityOAKDALE, MN
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSMITHS MEDICAL DELTEC IMPLANTABLE PORTS
Generic NamePORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
Product CodeLJT
Date Received2020-02-21
Model Number21-4155-24
Catalog Number21-4155-24
Lot Number3736572
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. Deathisabilit 2020-02-21

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