MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. -1424526 QUICKLINK LOADER; BRACHYTHERAPY EQUIPMENT & ACCESSORIES

Model Number	70310QCA1
Medical Device Problem Codes	Malposition of Device (2616); Difficult to Advance (2920); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the serial number for the device was provided, a manufacturing review 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.
Event or Problem Description
It was reported that during a procedure, the seeds were allegedly unable to be placed.There was no reported patient injury.
Additional Manufacturer Narrative
H10: the fda rn number for the initial mdr was inadvertently submitted as 2020394.The correct fda rn number was 1018233.H10: manufacturing review: a review of the device history record showed that this loader passed all quality inspection requirements prior to release.Investigation summary: the quicklink loader was not received for evaluation.The investigation is inconclusive for reported issue.The definitive root cause for the reported failure is unknown.Labeling review: the information for use was reviewed for quicklink delivery system.It is stated that never use visibly damaged, bent or broken quicklink¿ delivery system loaders, cartridges or components.This may cause system damage or jamming.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 procedure, the cartridge allegedly did not deliver the grains well.There was no reported patient injury.
Event or Problem Description
It was reported that during a brachytherapy procedure, the cartridge allegedly did not deliver the grains well.There was no reported patient injury.
Additional Manufacturer Narrative
H10: the fda rn number for the initial mdr was inadvertently submitted as 2020394.The correct fda rn number was 1018233.H10: manufacturing review: a review of the device history record showed that this loader passed all quality inspection requirements prior to release.Investigation summary: the sample was returned for evaluation.Upon evaluating the unit, the carriage pins were noted slightly bent causing friction during dispensing.The investigation is confirmed for reported issues.The root cause of damage carriage pins is unknown.Labeling review: labeling was reviewed and found to be adequate.It is stated that never use visibly damaged, bent or broken quicklink delivery system loaders, cartridges or components.This may cause system damage or jamming.H10: b5, g3, h2, h6 (device, method).H11: 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.H3 other text : see h10.

• Brand Name: QUICKLINK LOADER
• Common Device Name: BRACHYTHERAPY EQUIPMENT & ACCESSORIES
• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 11378159
• Report Number: 2020394-2021-00349
• Device Sequence Number: 4037503
• Product Code: IWJ
• UDI-Device Identifier: 00801741079238
• UDI-Public: (01)00801741079238
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 02/08/2022

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: 70310QCA1
• Device Catalogue Number: 70310QCA1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 03/30/2021; 02/09/2022
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 04/26/2021; 02/11/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown