MAUDE Adverse Event Report: QUICKLINK LOADER; BRACHYTHERAPY

Model Number	70310QCA1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history record could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.Device pending return.
Event or Problem Description
It was reported that there was a rattling noise in the bass of the quicklink delivery system.There was no reported patient injury.
Additional Manufacturer Narrative
H10: the event has been reassessed and determined to no longer be reportable.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 : device pending return.
Event or Problem Description
It was reported that there was a rattling noise in the bass of the quicklink delivery system.There was no reported patient injury.

• Brand Name: QUICKLINK LOADER
• Common Device Name: BRACHYTHERAPY
• MDR Report Key: 12577190
• Report Number: 1018233-2021-06210
• Device Sequence Number: 17003962
• Product Code: IWJ
• UDI-Device Identifier: 00801741079238
• UDI-Public: (01)00801741079238
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2021

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?: No
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 10/05/2021
• Supplement Report FDA Received Date: 10/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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