TRANSTAR SINGLE SET MXG300196

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2009-10-20 for TRANSTAR SINGLE SET MXG300196 manufactured by Smiths Medical Asd, Inc..

Event Text Entries

[15008988] The reporter stated that the flushing mechanism on the arterial line of the pressure monitoring set stuck and remained in the flush position. No adverse effects reported.
Patient Sequence No: 1, Text Type: D, B5


[15520490] (b) (4). Customer has not yet returned the device to the manufacturer for device evaluation. When and if the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2183502-2009-00350
MDR Report Key1517651
Report Source06,08
Date Received2009-10-20
Date of Report2009-10-19
Date of Event2009-08-17
Date Facility Aware2009-08-17
Report Date2009-10-19
Date Reported to FDA2009-10-19
Date Mfgr Received2009-09-21
Date Added to Maude2010-01-21
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 ContactPETE HIRTE
Manufacturer Street1265 GREY FOX RD.
Manufacturer CityST. PAUL MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone6516287384
Manufacturer G1SMITHS MEDICAL ASD
Manufacturer Street6250 SHIER-RINGS RD
Manufacturer CityDUBLIN OH 43016
Manufacturer CountryUS
Manufacturer Postal Code43016
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTRANSTAR SINGLE SET
Generic NamePRESSURE MONITORING SET
Product CodeDPT
Date Received2009-10-20
Model NumberNA
Catalog NumberMXG300196
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeNA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD, INC.
Manufacturer AddressDUBLIN OH US


Patients

Patient NumberTreatmentOutcomeDate
10 2009-10-20

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