MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. -1424526 QUICKLINK¿ CARTRIDGE 5.5MM STANDARD SOURCELINK¿; BRACHY

Model Number	70302QC10
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	01/12/2018
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 the seeds were stuck in the needle when the radiotherapist put them in place.The customer thought the problem came from the spacer.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that the seeds were stuck in the needle when the radiotherapist put them in place.The customer thought the problem came from the spacer.The customer kept some of the cartridges.
Event or Problem Description
It was reported that the seeds were stuck in the needle when the radiotherapist put them in place.The customer thought the problem came from the spacer.The customer kept some of the cartridges.
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: "condition: completed seed train does not load smoothly into the attached implant needle.Ensure needle adapter is appropriate for the implant needle used.".
Event or Problem Description
It was reported that the seeds were stuck in the needle when the radiotherapist put them in place.The customer thought the problem came from the spacer.The customer kept some of the cartridges.
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: "condition: completed seed train does not load smoothly into the attached implant needle.Ensure needle adapter is appropriate for the implant needle used.".

• Brand Name: QUICKLINK¿ CARTRIDGE 5.5MM STANDARD SOURCELINK¿
• Common Device Name: BRACHY
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream IL 60188
• MDR Report Key: 7241244
• Report Number: 1018233-2018-00333
• Device Sequence Number: 11056394
• Product Code: KXK
• UDI-Device Identifier: 10801741078092
• UDI-Public: (01)10801741078092
• 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: Radiologic Technologist
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/11/2018

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: 02/24/2018
• Device Model Number: 70302QC10
• Device Catalogue Number: 70301QC20
• Device Lot Number: BBBU0110
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2018
• Supplement Date Received by Manufacturer: 02/16/2018; 04/30/2018; 05/08/2018
• Initial Report FDA Received Date: 02/05/2018
• Supplement Report FDA Received Date: 03/15/2018; 05/01/2018; 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR