SAFE-T PLUS 4325SP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-27 for SAFE-T PLUS 4325SP manufactured by Carefusion 2200, Inc.

Event Text Entries

[68409575]
Patient Sequence No: 1, Text Type: N, H10


[68409576] Arthrograms performed on two different patients about one month ago, both cases experienced leaking at hub of arthrogram tubing.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6360574
MDR Report Key6360574
Date Received2017-02-27
Date of Report2017-01-16
Date of Event2017-01-13
Report Date2017-01-16
Date Reported to FDA2017-01-16
Date Reported to Mfgr2017-01-16
Date Added to Maude2017-02-27
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSAFE-T PLUS
Generic NameNEEDLE, SPINAL, SHORT TERM
Product CodeMIA
Date Received2017-02-27
Model Number4325SP
Catalog Number4325SP
Lot Number0001024651
Device Expiration Date2019-05-31
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCAREFUSION 2200, INC
Manufacturer Address400 EAST FOSTER RD MANNFORD OK 74044 US 74044


Patients

Patient NumberTreatmentOutcomeDate
10 2017-02-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.