Q2 T-EXTENSION SET 95702

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-03-08 for Q2 T-EXTENSION SET 95702 manufactured by Quest Medical, Inc..

Event Text Entries

[138570246] The alleged incident occurred outside the us. This medwatch is being submitted because quest medical distributes a similar device in the us. The complaint sample will be evaluated and a follow-up medwatch will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10


[138570247] A report was received regarding an alleged issue encountered during use of the iv administration extension set. The report states that the iv tubing pulled apart which resulted in a patient not receiving infusions and bleeding from central line insertion site. Additional information received indicates that the alleged malfunction did not result in patient complications.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1649914-2019-00010
MDR Report Key8405790
Report SourceDISTRIBUTOR
Date Received2019-03-08
Date of Report2019-04-11
Date Mfgr Received2019-02-07
Date Added to Maude2019-03-08
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 ContactTOSAN ONOSODE
Manufacturer StreetONE ALLENTOWN PARKWAY
Manufacturer CityALLEN TX 75002
Manufacturer CountryUS
Manufacturer Postal75002
Manufacturer Phone9723326338
Manufacturer G1QUEST MEDICAL, INC
Manufacturer StreetONE ALLENTOWN PARKWAY
Manufacturer CityALLEN TX 75002
Manufacturer CountryUS
Manufacturer Postal Code75002
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameQ2 T-EXTENSION SET
Generic NameINTRAVASCULAR ADMINISTRATION SET
Product CodeFPK
Date Received2019-03-08
Returned To Mfg2019-03-05
Model Number95702
Catalog Number95702
Lot Number0567388C03
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerQUEST MEDICAL, INC.
Manufacturer AddressONE ALLENTOWN PARKWAY ALLEN TX 75002 US 75002


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-08

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