MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. -1424526 QUICKLINK¿, SOURCELINK¿; BRACHYTHERAPY LINKS & CARTRIDGES

Catalog Number	70302QC10
Medical Device Problem Codes	Material Fragmentation (1261); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: manufacturing review: a finished good lot device history record (dhr) review was performed for the affected lot number of the cartridge, links, and tab.No issues were noted.Investigation summary: there was a sample returned for this complaint.During analysis the cartridge did not jam when dispensing the returned customer links nor sample/test links.However another issue of broken links were noted.Although the complaint is confirmed, a root cause could not be determined.Based on the inability to reproduce further, there was no root cause found and no further investigation is necessary.The reported complaint issue of ¿mechanical jam¿ is not confirmed, however damaged links were noted in the returned samples from the customer.The root cause of the broken links in undetermined.Labeling review: labeling was reviewed and found to be adequate.The information for use provided with quicklink packaged link finished goods is pk0319939 12/2018.There is a caution statement, which states "in the event the quicklink¿ loader or cartridges become inoperable due to damage or malfunction, any or all components may be removed from the cartridges and implanted manually." additionally, there is a troubleshooting section for "condition: pushing the dispense button does not eject any items or produces a partial dispense" with several steps listed to resolve this issue.It also has a note that states ¿the button must be pressed through its complete range of motion ¿ if the button is only pressed partially down, it will remain in the midrange position and prevent carriage motion or further dispensing.¿ there is a caution statement which states ¿extra care should be taken to avoid exposing the quicklink® cartridges containing bioabsorbable sourcelink¿ components to excessive heat or moisture.Store unopened packages at room temperature.Discard open, unused cartridges, sourcelink¿ connectors, and sourcelink¿spacers.Do not store bioabsorbable components at temperatures that exceed 40°c.¿ h11: section a through f ¿ the information provided 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 linker connector allegedly did not eject and got stuck at the entrance of the assembly base.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a finished good lot device history record (dhr) review was performed for the affected lot number of the cartridge, links, and tab.No issues were noted.Investigation summary: there was a sample returned for this complaint.During analysis the cartridge did not jam when dispensing the returned customer links nor sample/test links.However another issue of broken links were noted.Although the complaint is confirmed, a root cause could not be determined.Based on the inability to reproduce further, there was no root cause found and no further investigation is necessary.The reported complaint issue of ¿mechanical jam¿ is not confirmed, however damaged links were noted in the returned samples from the customer.The root cause of the broken links in undetermined.Labeling review: he information for use (ifu) provided with quicklink packaged link finished goods is pk0319939 12/2018.There is a caution statement, which states "in the event the quicklink¿ loader or cartridges become inoperable due to damage or malfunction, any or all components may be removed from the cartridges and implanted manually." additionally, there is a troubleshooting section for "condition: pushing the dispense button does not eject any items or produces a partial dispense" with several steps listed to resolve this issue.It also has a note that states ¿the button must be pressed through its complete range of motion ¿ if the button is only pressed partially down, it will remain in the midrange position and prevent carriage motion or further dispensing.¿ there is a caution statement which states ¿extra care should be taken to avoid exposing the quicklink® cartridges containing bioabsorbable sourcelink¿ components to excessive heat or moisture.Store unopened packages at room temperature.Discard open, unused cartridges, sourcelink¿ connectors, and sourcelink¿spacers.Do not store bioabsorbable components at temperatures that exceed 40°c.¿ h11: section a through f ¿ the information provided 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 linker connector allegedly did not eject and got stuck at the entrance of the assembly base.There was no reported patient injury.

• Brand Name: QUICKLINK¿, SOURCELINK¿
• Common Device Name: BRACHYTHERAPY LINKS & CARTRIDGES
• 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: 20816299
• Report Number: 1018233-2024-07647
• Device Sequence Number: 20796033
• Product Code: KXK
• UDI-Device Identifier: 10801741078092
• UDI-Public: (01)10801741078092
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K023210
• 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): 01/08/2025

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: 11/09/2024
• Device Catalogue Number: 70302QC10
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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