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

Model Number	PS1251LS
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 the facility received the incorrect number of seeds with the incorrect activity ((b)(4)).Per the complainant, "we had ordered a total of 82 seeds for plan 31, consisting of 76 seeds in needles plus 8 loose seeds for qa purposes.The vial of loose seeds we received contained 9 loose seeds.One of these seeds was not the correct activity for this patient.If there is any possibility that the needle activities could have been mixed up we will need to cancel the patient urgently.".
Additional Manufacturer Narrative
The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: ¿accountability and disposal i-125 is an accountable radioactive material.Brachysource seed implants should be strictly controlled and stored in a locked safe.If any radioactive material cannot be accounted for, the loss must be reported to the appropriate licensing agency.Records of receipt, storage and disposal of brachysource seed implants must be maintained in accordance with requirements of government regulatory agencies.When disposal is indicated, brachysource seed implants should be transferred to an authorized radioactive waste disposal agency.Brachysource seed implants should never be disposed of in normal waste.Bard brachytherapy, inc.Provides brachysource seed implants disposal service.Customers wishing to dispose of brachysource seed implants in this manner must contact your local representative or bard brachytherapy customer service, at (b)(6).Bard brachytherapy, inc.Will provide you with the instructions, forms and shipping containers required for shipment to bard brachytherapy, inc." (b)(4).
Event or Problem Description
It was reported that the facility received the incorrect number of seeds with the incorrect activity (b)(4).Per the complainant, "we had ordered a total of 82 seeds for plan 31, consisting of 76 seeds in needles plus 8 loose seeds for qa purposes.The vial of loose seeds we received contained 9 loose seeds.One of these seeds was not the correct activity for this patient.If there is any possibility that the needle activities could have been mixed up we will need to cancel the patient urgently.".

• 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: 6896962
• Report Number: 1018233-2017-05011
• Device Sequence Number: 13629512
• Product Code: KXK
• UDI-Device Identifier: 00801741078200
• UDI-Public: (01)00801741078200
• 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: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2017

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: PS1251LS
• Device Catalogue Number: PS1251LS
• Device Lot Number: BBBU0111
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/08/2017
• Supplement Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 09/27/2017
• Supplement Report FDA Received Date: 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1