MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. -1424526 BARD® BRACHYSOURCE® I-125 IMPLANT SEEDS IN CARTRIDGES; MICK CARTRIDGE

Model Number	1251CSF
Medical Device Problem Code	Device Inoperable (1663)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	01/09/2018
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 were not dispensing from the cartridge properly.The complainant reported that the sources were not dropping into the mick and were then getting bunched up and going everywhere.Seeds were reportedly found on the or table and on the floor at the end of the case.The complainant reported that the implant was "completed with full dosage and normal, expected outcome." one faulty cartridge will be returned with leftover 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: "do not unscrew magazines from applicator.Do not exceed the stated capacity of see per cartridge.Do not let seeds drop into the cartridge cavity.Do not use force on seeds; handle gently!" 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 seeds were not dispensing from the cartridge properly.The complainant reported that the sources were not dropping into the mick and were then getting bunched up and going everywhere.Seeds were reportedly found on the or table and on the floor at the end of the case.The complainant reported that the implant was "completed with full dosage and normal, expected outcome." one faulty cartridge will be returned with leftover seeds.

• Brand Name: BARD® BRACHYSOURCE® I-125 IMPLANT SEEDS IN CARTRIDGES
• Common Device Name: MICK CARTRIDGE
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream IL 60188
• MDR Report Key: 7227228
• Report Number: 1018233-2018-00259
• Device Sequence Number: 19144987
• Product Code: KXK
• UDI-Device Identifier: 00801741078248
• UDI-Public: (01)00801741078248
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K140856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2018

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: 1251CSF
• Device Catalogue Number: 1251CSF
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/09/2018
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 01/30/2018
• Supplement Report FDA Received Date: 05/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1