MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 QUICKLINK LOADER

Model Number	70310QCA1
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.
Event or Problem Description
It was reported that the second button on the left of the quicklink loader was staying downward and would not automatically come up.Additional information was received via email on 07nov2019.The issue was found during procedure and did cause some delay, as they had to find another device to complete the procedure.
Event or Problem Description
It was reported that the second button on the left of the quicklink loader was staying downward and would not automatically come up.Additional information was received via email on 07nov2019.The issue was found during procedure and did cause some delay, as they had to find another device to complete the procedure.
Additional Manufacturer Narrative
The quicklink loader serial number (b)(4) was received and evaluated.During the evaluation, the dispense button was not found in the downward position, and it worked as intended.Hence, this complaint is deemed unconfirmed.Additionally, the dispensing process during the evaluation felt gritty/sticky.The slight sticking was being caused from the burrs present on top of the blade.The burrs on blade were formed from stylet being pushed while dispense button was in lock out position as the failure experienced by customer.The root cause for the sticky dispensing was due to the compression slide handle was not fully retracted to the right before assembling a seed train.The unit was repaired, tested and then released for distribution.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "retract the compression slide handle to the right until it contacts the rear plate to seat the slide compression mechanism (if unseated)." and "condition: pushing the dispense button does not eject any items or produces a partial dispense" walks through the troubleshooting for the failure alleged in this complaint.".

• Brand Name: QUICKLINK LOADER
• Common Device Name: QUICKLINK LOADER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9386805
• Report Number: 1018233-2019-07619
• Device Sequence Number: 2287337
• Product Code: IWJ
• UDI-Device Identifier: 00801741079238
• UDI-Public: (01)00801741079238
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2020

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: 10/17/2019
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 05/15/2020
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 05/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1