MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. -1424526 MODEL 200 THERASEED® PALLADIUM-103 IN CARTRIDGES

Model Number	TS200C
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 there was no independent assay provided with the seeds.It was also reported that the patient decided to abandon brachytherapy treatment all together.
Additional Manufacturer Narrative
The complaint was confirmed, and the root cause was manufacturing-related.Specifically, the 10% assay was not performed by sterile products lab technicians nor was the deficiency identified by the quality technician who released the order for sterilization processing.Defect awareness training was performed.Labeling was inadequate as the 10% assay certificate was missing from the customer's order.(b)(4).The device was not returned.
Event or Problem Description
It was reported that there was no independent assay provided with the seeds.It was also reported that the patient decided to abandon brachytherapy treatment all together.

• Brand Name: MODEL 200 THERASEED® PALLADIUM-103 IN CARTRIDGES
• Common Device Name: THERASEED
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream IL 60188
• MDR Report Key: 6594178
• Report Number: 1018233-2017-02730
• Device Sequence Number: 10789573
• Product Code: KXK
• UDI-Device Identifier: 00801741078408
• UDI-Public: (01)00801741078408
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K060636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2017

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: TS200C
• Device Catalogue Number: TS200C
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/05/2017
• Supplement Date Received by Manufacturer: 06/26/2017
• Initial Report FDA Received Date: 05/26/2017
• Supplement Report FDA Received Date: 07/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1