MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWER-TRIALYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER KIT (13 F) (15CM) (TRIPLE-; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.[(b)(4)].
Event or Problem Description
It was reported via medwatch that the securement on the device allows it to move within the vessel and came out of the vessel.Patient was receiving crrt when line came out.Rn was giving medication for procedure and line had come out.New line was placed.

• Brand Name: POWER-TRIALYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER KIT (13 F) (15CM) (TRIPLE-
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8723350
• Report Number: 3006260740-2019-01725
• Device Sequence Number: 2003807
• Product Code: NIE
• UDI-Device Identifier: 00801741041853
• UDI-Public: (01)00801741041853
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K133456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/21/2019
• Report Date (Section F): 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 5603150
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 05/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR