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

[93688998] At the time of this report, the device has not been returned for investigation. A follow medwatch will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10


[93688999] A customer report received states that the clamps on the extension set side tubing is falling off and at least 2 sets have lost their side clamp. They have had to open a new set to retrieve a clamp for replacement of the defective clamp.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1649914-2017-00096
MDR Report Key7064304
Date Received2017-11-28
Date of Report2018-01-18
Date Mfgr Received2017-10-31
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
Model Number95906
OperatorNURSE
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
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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