TRANSTAR PRESSURE MONITORING SYSTEM MX9505T

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-11-25 for TRANSTAR PRESSURE MONITORING SYSTEM MX9505T manufactured by Smiths Medical, Inc..

Event Text Entries

[5057145] A report was received stating during set-up, tubing separation occurred at the non-fused male luer lock. As this issue was found during set-up, there was no pt involvement.
Patient Sequence No: 1, Text Type: D, B5


[12454210] The device was not returned to the mfr for device eval. When and if the device becomes available and is returned for eval, the mfr will file a f/u report detailing the results of the eval.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2183502-2014-00907
MDR Report Key4298351
Report Source06
Date Received2014-11-25
Date of Report2014-11-25
Report Date2014-11-25
Date Reported to FDA2014-11-25
Date Mfgr Received2014-11-07
Device Manufacturer Date2014-04-11
Date Added to Maude2014-12-05
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
Manufacturer Street5700 W 23RD AVE.
Manufacturer CityGARY IN 46406
Manufacturer CountryUS
Manufacturer Postal Code46406
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTRANSTAR PRESSURE MONITORING SYSTEM
Generic NameDPT - PROBE, BLOOD-FLOW, EXTRAVASCULAR
Product CodeDPT
Date Received2014-11-25
Model NumberNA
Catalog NumberMX9505T
Lot Number2671636
ID NumberNA
Device Expiration Date2017-03-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeNA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL, INC.
Manufacturer AddressDUBLIN OH US


Patients

Patient NumberTreatmentOutcomeDate
10 2014-11-25

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