BARD? QUICKLINK? CARTRIDGES WITH BRACHYSOURCE? I-125 SEEDS 1251QCL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-29 for BARD? QUICKLINK? CARTRIDGES WITH BRACHYSOURCE? I-125 SEEDS 1251QCL manufactured by Bard Brachytherapy, Inc. -1424526.

Event Text Entries

[96225944] The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10


[96225945] It was reported that the seeds would not come out of our calibration cartridge no matter how many times it was reloaded, re-aligned, pushed down on it etc, etc nothing happened. There appeared to be some sort of misalignment as the? Expel? Button was just solid and wouldn? T depress properly. Also, on a second cartridge a seed fell through the loader and onto the baseplate, but we have had that on one other previous occasion. It just appeared to fall out ie. "i didn? T try and load it into a source train and it just didn? T appear in the source train window requiring me to have a second attempt of depressing the? Expel? Button. " all source trains made up ok from that cartridge but it was just at the end of the cartridge that a seed was? Missing? Ie. "i had 1 less seed in the cartridge than i was expecting namely the one that had fallen through. " the patient did not received all seeds.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2017-06520
MDR Report Key7155458
Date Received2017-12-29
Date of Report2018-02-01
Date Mfgr Received2018-01-29
Date Added to Maude2017-12-29
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 ContactAMY GRAVLEY
Manufacturer Street8195 INDUSTRIAL BLVD
Manufacturer CityCOVINGTON GA 30014
Manufacturer CountryUS
Manufacturer Postal30014
Manufacturer Phone7707846100
Manufacturer G1BARD BRACHYTHERAPY, INC. -1424526
Manufacturer Street295 EAST LIES ROAD
Manufacturer CityCAROL STREAM IL 60188
Manufacturer CountryUS
Manufacturer Postal Code60188
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameBARD? QUICKLINK? CARTRIDGES WITH BRACHYSOURCE? I-125 SEEDS
Generic NameSEEDS
Product CodeKXK
Date Received2017-12-29
Model Number1251QCL
Catalog Number1251QCL
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBARD BRACHYTHERAPY, INC. -1424526
Manufacturer Address295 EAST LIES ROAD CAROL STREAM IL 60188 US 60188


Patients

Patient NumberTreatmentOutcomeDate
10 2017-12-29

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