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

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-17 for BARD? QUICKLINK? CARTRIDGES WITH BRACHYSOURCE? I-125 SEEDS 1251QCS manufactured by Bard Brachytherapy, Inc. -1424526.

Event Text Entries

[93124137] The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10


[93124138] It was reported that the facility received the correct order of seeds with the incorrect implant date. The original order was received and processed on (b)(6) 2017 to have an implant date of (b)(6) 2017 with a seed reference date of (b)(6) 2017. On (b)(6) 2017, a revision request for this order was received from the customer and the implant date was changed to (b)(6) 2017 with the reference date of (b)(6) 2017, per the customer? S request. The new order was printed on (b)(6) 2017 which reflected the revised dates. However; the order that was filled and shipped to the customer had the original (incorrect) dates on the assay cert and labels. The patient received all the seeds as planned.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2017-05954
MDR Report Key7040656
Date Received2017-11-17
Date of Report2018-01-31
Date Mfgr Received2018-01-29
Date Added to Maude2017-11-17
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 NameBRACHY SEEDS
Product CodeKXK
Date Received2017-11-17
Catalog Number1251QCS
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 2017-11-17

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