MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. -1424526 QUICKLINK¿ CARTRIDGE 5.0MM EXTENSION SOURCELINK¿; BRACHYTHERAPY

Model Number	70303QC20
Medical Device Problem Code	Sticking (1597)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/19/2018
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.The device was not returned.
Event or Problem Description
It was reported that after compacting a train of extension, the seed train hung in the end of the quicklink.It was noted that the tip of the extension was crushed.Two attempts later, the expansion bar was changed to eliminate a batch problem, however the issue persisted.The quicklink was then changed, and so was the extension bar, in addition to compressing the grain train at a slower pace.
Event or Problem Description
It was reported that after compacting a train of extension, the seed train hung in the end of the quicklink.It was noted that the tip of the extension was crushed.Two attempts later, the expansion bar was changed to eliminate a batch problem, however the issue persisted.The quicklink was then changed, and so was the extension bar, in addition to compressing the grain train at a slower pace.
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: ¿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." the device was not returned.

• Brand Name: QUICKLINK¿ CARTRIDGE 5.0MM EXTENSION SOURCELINK¿
• Common Device Name: BRACHYTHERAPY
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream IL 60188
• MDR Report Key: 7356729
• Report Number: 1018233-2018-00893
• Device Sequence Number: 19113675
• Product Code: KXK
• UDI-Device Identifier: 10801741078115
• UDI-Public: (01)10801741078115
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K023210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2018

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 Expiration Date: 04/01/2018
• Device Model Number: 70303QC20
• Device Catalogue Number: 70303QC20
• Device Lot Number: BBBV0102
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2018
• Supplement Date Received by Manufacturer: 05/18/2018
• Initial Report FDA Received Date: 03/21/2018
• Supplement Report FDA Received Date: 05/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 87