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

Model Number	1251QCL
Health Effect - Clinical Code	Therapeutic Effects, Unexpected (2099)
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.The device was not returned.
Event or Problem Description
It was reported that the cartridge jammed.The seeds were stuck in the cartridge and the patient did not receive all the seeds as planned.
Event or Problem Description
It was reported that the cartridge jammed.The seeds were stuck in the cartridge and the patient did not receive all the seeds as planned.
Additional Manufacturer Narrative
The device was not returned for evaluation.There is no lot number associated with the product code; 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.Troubleshooting condition: pushing the dispense button does not eject any items or produces a partial dispense.¿ ensure that the handle is not being pulled while the dispense button is being depressed.Pulling on the handle during dispensing can cause the cartridge to become misaligned with the dispense track, resulting in a lock out or a jam; ¿ ensure the selected cartridge is fully seated in the corresponding carriage receptacle; ¿ remove cartridge from carriage and reinsert back into the carriage; ¿ ensure the dispense blade is not jammed - remove the carriage and inspect dispense blade, verify there are no loose components; ¿ the selected cartridge is empty - replace with a full cartridge; ¿ the dispense button is not fully depressed - press button fully; ¿ if cartridge does not dispense following troubleshooting, replace cartridge." (b)(4).

• Brand Name: BARD® QUICKLINK¿ CARTRIDGES WITH BRACHYSOURCE® I-125 SEEDS
• Common Device Name: BRACHY SEEDS
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream IL 60188
• MDR Report Key: 7157958
• Report Number: 1018233-2018-00004
• Device Sequence Number: 1340361
• 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: Patient
• 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: 12/11/2017
• Supplement Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 01/02/2018
• 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