MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. -1424526 BARD® QUICKLINK¿ CARTRIDGES WITH BRACHYSOURCE® I-125 SEEDS

Model Number	1251QCL
Health Effect - Clinical Code	Radiation Underdose (2166)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "in the event the quicklink loader or cartridges become inoperable due to damage or malfunction, any or all components may be removed from the cartridges and implanted manually.Pushing the dispense button does not eject any items or produces a partial dispense." (b)(4).
Event or Problem Description
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.

• Brand Name: BARD® QUICKLINK¿ CARTRIDGES WITH BRACHYSOURCE® I-125 SEEDS
• Common Device Name: SEEDS
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream IL 60188
• MDR Report Key: 7155458
• Report Number: 1018233-2017-06520
• Device Sequence Number: 16638935
• Product Code: KXK
• UDI-Device Identifier: 00801741078378
• UDI-Public: (01)00801741078378
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K093663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1251QCL
• Device Catalogue Number: 1251QCL
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 12/29/2017
• Supplement Report FDA Received Date: 02/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1