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

Model Number	70310QCA1
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the serial number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that during a procedure, the grains allegedly failed to line up correctly when percussing.It was further reported that they were allegedly struck.There was no reported patient injury.
Additional Manufacturer Narrative
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 received and evaluated.The carriage was not initially received with the loader.The carriage was received later.During the evaluation, ¿taped¿ cartridges, which are sample cartridges used by the service depot for testing, were used to test the loader.The loader functioned as normal.Further evaluation suggested that the carriage had been dropped, there was also a deep scratch on the side of the blade.The blade was touching the side of the slot cover during dispensing.The blade was replaced as it appeared that the loader could have been dropped causing slight misalignments in the mechanism.After the damaged components were replaced and the loader was re-aligned and lubricated, the loader functioned as normal.T.This complaint reported failure is inconclusive.The cause of the damaged blade and broken/cracked parts in this case is unknown.They can potentially occur due to the unit being dropped.The overall root cause of the alleged failure is undetermined as the alleged failure could not be reproduced.Labeling review: labeling document was reviewed and deemed to be adequate.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.H10: g3, h8.H11: h6 (method, result, conclusion).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.H3 other text : see h10.
Event or Problem Description
It was reported that during a brachytherapy procedure, grains allegedly failed to line up correctly when percussing.It was further reported that they were allegedly stuck.There was no reported patient injury.
Event or Problem Description
It was reported that during a brachytherapy procedure, grains allegedly failed to line up correctly when percussing.It was further reported that they were allegedly stuck.There was no reported patient injury.
Additional Manufacturer Narrative
H10: the fda rn number for the mdr 2020394-2021-00722 was inadvertently submitted as (b)(4).The correct fda rn number was (b)(4).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 received and evaluated.The carriage was not initially received with the loader.The carriage was received later.During the evaluation, ¿taped¿ cartridges, which are sample cartridges used by the service depot for testing, were used to test the loader.The loader functioned as normal.Further evaluation suggested that the carriage had been dropped, there was also a deep scratch on the side of the blade.The blade was touching the side of the slot cover during dispensing.The blade was replaced as it appeared that the loader could have been dropped causing slight misalignments in the mechanism.After the damaged components were replaced and the loader was re-aligned and lubricated, the loader functioned as normal.This complaint reported failure is inconclusive.The cause of the damaged blade and broken/cracked parts in this case is unknown.They can potentially occur due to the unit being dropped.The overall root cause of the alleged failure is undetermined as the alleged failure could not be reproduced.Labeling review: labeling document was reviewed and deemed to be adequate.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 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.

• 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: 11580794
• Report Number: 2020394-2021-00722
• Device Sequence Number: 4108305
• 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: 03/02/2021
• Supplement Date Received by Manufacturer: 01/25/2022; 02/12/2022
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 02/02/2022; 02/16/2022
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown