MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWER TRIALYSIS, INTL, 20CM, ST, ACUTE DIALYSIS KIT; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON IMPLANTED

Model Number	5608200
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of rebq1796 showed no other similar product complaint(s) from this lot number.Device, not yet returned.
Event or Problem Description
The doctor reported the hub broke off upon the catheter insertion.No patient injury was reported.This file addressed the initial device.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of rebq1796 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The doctor reported the hub broke off upon the catheter insertion.No patient injury was reported.This file addressed the initial device.

• Brand Name: POWER TRIALYSIS, INTL, 20CM, ST, ACUTE DIALYSIS KIT
• 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: 6886449
• Report Number: 3006260740-2017-01679
• Device Sequence Number: 13477410
• Product Code: NIE
• UDI-Device Identifier: 00801741041907
• UDI-Public: (01)00801741041907
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K133456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2018

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 Model Number: 5608200
• Device Catalogue Number: 5608200
• Device Lot Number: REBQ1796
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 09/22/2017
• Supplement Report FDA Received Date: 03/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1