MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. -1424526 QUICKLINK DELIVERY SYSTEM QUICKLINK LOADER; QUICK LINK LOADER

Model Number	70310QCA1
Medical Device Problem Code	Solder Joint Fracture (2324)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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 device was not returned.
Event or Problem Description
It was reported that the criticore monitor had broken leaded glass and the movement of the carriage was not fluid.
Event or Problem Description
It was reported that the quicklink loader had broken leaded glass.It was also noted that the movement of the carriage was not fluid.Per follow up, it was noted that the device was used on a patient during the event, but there were no clinical consequences.
Additional Manufacturer Narrative
The quicklink loader serial number (b)(6) was received and evaluated.During the evaluation, the unit exhibited the failures that were alleged.Therefore, the complaint is confirmed.The evaluation report attached with the complaint includes pictures of the cracked leaded glass door and its interference with the carriage as the objective evidence.The root cause for the cracked plastic door is undetermined.The potential cause could be stress created during autoclaving.The carriage movement issue was caused by the rubbing of deformed plastic door.The unit was repaired, tested and then released for distribution.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 DELIVERY SYSTEM QUICKLINK LOADER
• Common Device Name: QUICK LINK LOADER
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream IL 60188
• MDR Report Key: 9146143
• Report Number: 1018233-2019-06165
• Device Sequence Number: 2498154
• 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): 07/22/2020

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: 02/05/2020
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1