JELCO? IV CATHETER 4038-AI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2020-03-31 for JELCO? IV CATHETER 4038-AI manufactured by Smiths Medical Asd; Inc..

Event Text Entries

[185915450] Information was received indicating that upon removal of a smiths medical jelco iv catheter, the cannula broke off in the patient. The patient was reported to be taken to surgery for successful removal of the retained piece. The patient recovered and was discharged. There were no further reported adverse effects.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2020-02640
MDR Report Key9908301
Report SourceDISTRIBUTOR,FOREIGN,USER FACI
Date Received2020-03-31
Date of Report2020-03-30
Date of Event2020-01-28
Date Mfgr Received2020-02-29
Device Manufacturer Date2018-12-07
Date Added to Maude2020-03-31
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 Street1500, EUREKA PARK LOWER PEMBERTON
Manufacturer CityASHFORD, KENT TN254BF
Manufacturer CountryUK
Manufacturer Postal CodeTN25 4BF
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameJELCO? IV CATHETER
Generic NameCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Product CodeFOZ
Date Received2020-03-31
Returned To Mfg2020-03-25
Catalog Number4038-AI
Lot Number3738126
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD; INC.
Manufacturer Address6000 NATHAN LANE N MINNEAPOLIS,, MN US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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