Q2 IV EXTENSION SET 95906

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-28 for Q2 IV EXTENSION SET 95906 manufactured by Quest Medical, Inc.

Event Text Entries

[93689079] The device has been returned for investigation which is in progress. A follow medwatch will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10


[93689080] A customer reported an issue encountered with the q2 extension set. The report states that blood leaked from the q2 port following removal of the pivo. The nurse attempted to flush the q2 to stop the blood. It stopped while flushing then continued leaking. After replacing the q2 the leaking stopped. There were no patient complications resulting from the alleged issue.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1649914-2017-00094
MDR Report Key7064309
Date Received2017-11-28
Date of Report2018-02-16
Date Mfgr Received2017-11-01
Date Added to Maude2017-11-28
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 Report0

Device Details

Brand NameQ2 IV EXTENSION SET
Generic NameIV EXTENSION SETS
Product CodeFPK
Date Received2017-11-28
Returned To Mfg2017-11-15
Model Number95906
OperatorNURSE
Device AvailabilityR
Device AgeDA
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
101. Required No Informationntervention 2017-11-28

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