BARD? BRACHYSOURCE? I-125 IMPLANT SEED PS1251LS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-04 for BARD? BRACHYSOURCE? I-125 IMPLANT SEED PS1251LS manufactured by Bard Brachytherapy, Inc. -1424526.

Event Text Entries

[107715451] The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. (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. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10


[107715452] It was reported that the facility received seeds with product codes 1251csr and 1251csra (sales order (b)(4)) that were intended for a different facility instead of the seeds that were ordered (ps1251ls - sales order (b)(4)). The initial investigation into the issue indicates that the fedex labels on the outer shipping boxes were switched. The patient was reportedly unable to undergo the scheduled surgery and an additional surgery was scheduled for a later date. This facility was unable to complete the scheduled procedure for their patient; therefore, an additional surgery was scheduled. However, the seeds alleged against (ps1251ls) were used on a patient at another facility ((b)(6) hospital) per additional information received, the patient's surgery was rescheduled and completed on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2018-01525
MDR Report Key7488238
Date Received2018-05-04
Date of Report2018-07-13
Date of Event2018-04-09
Date Mfgr Received2018-07-05
Device Manufacturer Date2018-03-19
Date Added to Maude2018-05-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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? BRACHYSOURCE? I-125 IMPLANT SEED
Generic NameSEEDS
Product CodeKXK
Date Received2018-05-04
Returned To Mfg2018-04-30
Model NumberPS1251LS
Catalog NumberPS1251LS
Lot NumberBBCQ0050
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 2018-05-04

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