MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. -1424526 BARD® BRACHYSOURCE® I-125 IMPLANT SEED; I125 QUICKLINK CARTRIDGE SINGLE

Model Number	1251QCL
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
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: "i-125 has a 59.6 day half life1.Decay corrections must be made to properly calculate the activity of the brachysource® seed implants from the labeled reference date to the day they are implanted.To correct for the physical decay of iodine-125, the decay factors at selected days before and after the assay date are shown in the table below:" (b)(4).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 seed activity on the local assay was not in the normal agreement with each other.(the facility verified this from their seed activity measurements and paperwork) due to the concern over the correct activity, the physician chose to cancel the (b)(6) 2017 implant and reschedule with a new set of seeds for implant on (b)(6) 2017.This is the extent of the information available.

• Brand Name: BARD® BRACHYSOURCE® I-125 IMPLANT SEED
• Common Device Name: I125 QUICKLINK CARTRIDGE SINGLE
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream IL 60188
• MDR Report Key: 7015186
• Report Number: 1018233-2017-05790
• Device Sequence Number: 444651
• Product Code: KXK
• UDI-Device Identifier: 00801741078378
• UDI-Public: (01)00801741078378
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K093663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Physicist
• Type of Report: Initial
• Report Date (Section B): 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2017
• Initial Report FDA Received Date: 11/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention