Q2 8.5 INCH DOUBLE T-SITE IV EXTENSION SET 95711

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-18 for Q2 8.5 INCH DOUBLE T-SITE IV EXTENSION SET 95711 manufactured by Quest Medical, Inc..

Event Text Entries

[57868103] Quest medical, inc. Has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported. Quest medical, inc. Defers to the patient's physician regarding medical history.
Patient Sequence No: 1, Text Type: N, H10


[57868104] The distributor reported an issue encountered by one of their customers when using the iv administration extension set. The report stated that a 20cc luer lock syringe full of blood was attached to one of the device ports, and upon injection into the port blood squirted out of another port. The report stated the device was discarded and another manifold was used. The patient was 5 months old and the iv line was attached to an internal jugular central line. The complainant stated there was no harm caused to the patient but that the issue had occurrec in three different procedures. The complainant chose to return seven of the unused device to the distributor for analysis by the manufacturer.
Patient Sequence No: 1, Text Type: D, B5


[58947687] The complainant returned one device sample out of the package and six other devices (same lot) still sealed in their packages. The one device sample appeared to have not been used. Visual examination of the device found no anomalies. All seven samples were primed wtih water using a 20 cc syringe, to similate the conditions stated by the user. None of the samples leaked or squirted water from the port per the complaint. The device history record for the lot was reviewed and no devices were rejected and no specific manufacturing yield issues were reported similar to the reported complaint condition.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1649914-2016-00049
MDR Report Key6037669
Date Received2016-10-18
Date of Report2016-10-27
Date of Event2016-09-19
Date Mfgr Received2016-09-19
Device Manufacturer Date2015-05-04
Date Added to Maude2016-10-18
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 ContactMRS. AMY CLENDENING-WHEELER
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 8.5 INCH DOUBLE T-SITE IV EXTENSION SET
Generic NameINTRAVASCULAR ADMINISTRATION EXTENSION SET
Product CodeFPK
Date Received2016-10-18
Returned To Mfg2016-09-22
Model Number95711
Lot Number0489865Y03
Device Expiration Date2018-05-01
OperatorPHYSICIAN
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
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 2016-10-18

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