MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. -1424526 BARD® BRACHYSOURCE® I-125 IMPLANT SEED; SEEDS

Model Number	PS1251LS
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/07/2018
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 when the complainant opened the vial to extract the seeds, there was a powdery black substance that spilled from the container.The reported event occurred before patient involvement.
Additional Manufacturer Narrative
The reported issue was confirmed.The device was returned for evaluation.The visual inspection noted black particulates in close proximity to the seeds.However, these particulates were not consistent with anything included in the manufacturing and order filling process.The origin of the black particulates was unknown.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use states the following: ¿brachysources are hermetically sealed in a welded titanium capsule consisting of unalloyed titanium, providing exceptional tissue biocompatibility.".
Event or Problem Description
It was reported that when the complainant opened the vial to extract the seeds, there was a powdery black substance that spilled from the containiner.The reported event occurred before patient involvement.

• Brand Name: BARD® BRACHYSOURCE® I-125 IMPLANT SEED
• Common Device Name: SEEDS
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream IL 60188
• MDR Report Key: 7373873
• Report Number: 1018233-2018-00961
• Device Sequence Number: 10789736
• Product Code: KXK
• UDI-Device Identifier: 00801741078200
• UDI-Public: (01)00801741078200
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K093663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2018

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: PS1251LS
• Device Catalogue Number: PS1251LS
• Device Lot Number: BBCP0024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Initial Date Received by Manufacturer: 03/08/2018
• Supplement Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 03/27/2018
• Supplement Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1