MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. -1424526 BRACHYSTAR FASTFILL SEED IMPLANT NEEDLE; BRACHYTHERAPY IMPLANT NEEDLES

Catalog Number	818205
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H11: section a through f - the information provided by bd 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 bd.
Event or Problem Description
It was reported that during a brachytherapy procedure, the wax allegedly dislodged from the tip of the needle.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufcaturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was not returned for evaluation.Three electronic photos were received, and it was reviewed.The provided two photos shows eight needles in which seven needles were noted to have bone wax is exposed in the cannula.However, based on the clear examination, this damage was noted to be related to the process, the cause may have been caused during handling outside of bd controls.The third photo shows the labelling information which matches/verifies with the tw details.Based on the photo review, the reported device contamination can be confirmed.Therefore, the investigation is confirmed for the reported device contamination as the needles in the provided photo shows bone wax exposed in the cannula.A definitive root cause for the reported device contamination could not be determined based upon the provided information.It may have happened due to the handling of the device.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: g3, h6 (method) h11: d4(unique identifier (udi) #), h6 (result) h11: section a through f: the information provide by bd represents all 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 bd.
Event or Problem Description
It was reported that during a brachytherapy procedure, the wax allegedly dislodged from the tip of the needle.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: BRACHYSTAR FASTFILL SEED IMPLANT NEEDLE
• Common Device Name: BRACHYTHERAPY IMPLANT NEEDLES
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream 60188
• Manufacturer (Section G): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream 60188
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 21133253
• Report Number: 1018233-2025-00074
• Device Sequence Number: 7491479
• Product Code: IWJ
• UDI-Device Identifier: 10801741124119
• UDI-Public: (01)10801741124119(11)240913(17)250831(10)REJW0252
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2025

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 Expiration Date: 08/31/2025
• Device Catalogue Number: 818205
• Device Lot Number: REJW0252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 01/11/2025
• Supplement Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown