MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. -1424526 QUICKLINK¿ LOADER; QUICKLINK LOADER

Catalog Number	70310QCA1
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/22/2018
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 during a 3/4 curietherapie procedure there was a problem with the quicklink applicator.It had blocked due to the failure to tighten a screw located under the rack, preventing the advance of the needle.The screw was loosened during the procedure since the tests and the preparation of 12 needles before had been carried out without difficulty.The customer had to take a new applicator to complete the procedure.There was an extended operating time for the patient of about 10 minutes.
Additional Manufacturer Narrative
Upon further review, bard medical has determined that this mdr was initially reported in error as this event is not reportable.
Event or Problem Description
It was reported that during a 3/4 curietherapie procedure there was a problem with the quicklink applicator.It had blocked due to the failure to tighten a screw located under the rack, preventing the advance of the needle.The screw was loosened during the procedure since the tests and the preparation of 12 needles before had been carried out without difficulty.The customer had to take a new applicator to complete the procedure.There was an extended operating time for the patient of about 10 minutes.

• Brand Name: QUICKLINK¿ LOADER
• Common Device Name: QUICKLINK LOADER
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream IL 60188
• MDR Report Key: 7336173
• Report Number: 1018233-2018-00797
• Device Sequence Number: 1589385
• Product Code: IWJ
• UDI-Device Identifier: 00801741079238
• UDI-Public: (01)00801741079238
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2018

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 Catalogue Number: 70310QCA1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Initial Date Received by Manufacturer: 02/23/2018
• Supplement Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 03/13/2018
• Supplement Report FDA Received Date: 03/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR