BARD? BRACHYSOURCE? I-125 IMPLANT SEEDS IN CARTRIDGES 1251CSRA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-03 for BARD? BRACHYSOURCE? I-125 IMPLANT SEEDS IN CARTRIDGES 1251CSRA manufactured by Bard Brachytherapy, Inc. -1424526.

Event Text Entries

[107528015] The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. Bm (b)(4) is associated with this event. 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


[107528016] It was reported that the facility received seeds with product code (b)(4) (sales order (b)(4)) that were intended for a different facility, instead of the seeds that were ordered (1251csr and 1251csra - sales order (b)(4)). The initial investigation into the issue indicated that the fedex labels on the outer shipping boxes were switched. The seeds that the facility received ((b)(4)) were reportedly used on the patient and the patient received the correct dosage without impact.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2018-01483
MDR Report Key7485827
Date Received2018-05-03
Date of Report2018-09-19
Date of Event2018-04-09
Date Mfgr Received2018-08-27
Date Added to Maude2018-05-03
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 ContactYONIC ANDERSON
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? BRACHYSOURCE? I-125 IMPLANT SEEDS IN CARTRIDGES
Generic NameSEEDS
Product CodeKXK
Date Received2018-05-03
Returned To Mfg2018-04-16
Catalog Number1251CSRA
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
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 2018-05-03

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