BARD? BRACHYSOURCE? I-125 IMPLANT SEEDS IN CARTRIDGES PS-1251CS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2018-02-01 for BARD? BRACHYSOURCE? I-125 IMPLANT SEEDS IN CARTRIDGES PS-1251CS manufactured by Bard Brachytherapy, Inc. -1424526.

Event Text Entries

[98840859] 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


[98840860] It was reported that the plunger had to be tapped after releasing the first seed in order to lower the second and subsequent seeds. The patient received all seeds as planned. The failings caused re-introductions of needles and sub-optimal control of implant geometry.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2018-00303
MDR Report Key7234554
Report SourceCOMPANY REPRESENTATIVE,OTHER
Date Received2018-02-01
Date of Report2018-04-13
Date of Event2017-11-13
Date Mfgr Received2018-04-12
Date Added to Maude2018-02-01
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRADIOLOGIC TECHNOLOGIST
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 Report3

Device Details

Brand NameBARD? BRACHYSOURCE? I-125 IMPLANT SEEDS IN CARTRIDGES
Generic NameBRACHY CARTRIDGE
Product CodeKXK
Date Received2018-02-01
Catalog NumberPS-1251CS
Lot NumberNA
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
101. Required No Informationntervention 2018-02-01

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