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

Model Number	70310QCA1
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not 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.Device not returned.
Event or Problem Description
It was reported that during a procedure, the silver nozzle tip allegedly misaligned with space and groove causing jams when attempting to load needles.There was no reported patient injury.
Event or Problem Description
It was reported that during a procedure, the silver nozzle tip allegedly misaligned with space and groove causing jams when attempting to load needles.There was no reported patient injury.
Additional Manufacturer Narrative
H10: the fda rn number for the mdr 2020394-2021-00272 was inadvertently submitted as 2020394.The correct fda rn number was 1018233.H10: manufacturing review: the device history record review was performed for the reported serial number.A review of the device history record showed that this loader passed all quality inspection requirements prior to release.Additionally, the device history record for gate plate was reviewed.It was accepted and released with no issues.Investigation summary: the quicklink loader was received and evaluated.During the evaluation, the needle adapter was misaligned with the track.The investigation is confirmed for the reported issue.The root cause was determined to be supplier-manufacturing defect.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.

• Brand Name: QUICKLINK LOADER
• Common Device Name: BRACHYTHERAPY EQUIPMENT & ACCESSORIES
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11336498
• Report Number: 2020394-2021-00272
• Device Sequence Number: 16989703
• Product Code: IWJ
• UDI-Device Identifier: 00801741079238
• UDI-Public: (01)00801741079238
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2021

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Initial Date Received by Manufacturer: 01/22/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other