MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DUOGLIDE SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER KIT 13F (DUAL-LUMEN) (15C; BLOOD ACCESS DEVICE AND ACCESSORIES

Catalog Number	5624150
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that the extension on the 15cm duoglide kinked/collapsed during crrt.The line was positioned in the jugular and when it was hooked up for "continuous", a memory in the clear extension portion of the catheter reportedly became extremely soft and resulted in the machine stopping.It was reported that the machine usually runs up to 300 but could only achieve 200-250.The line stopped working altogether and a new line was required.No patient injury reported.

• Brand Name: DUOGLIDE SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER KIT 13F (DUAL-LUMEN) (15C
• Common Device Name: BLOOD ACCESS DEVICE AND ACCESSORIES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 5536719
• Report Number: 3006260740-2016-00137
• Device Sequence Number: 895634
• Product Code: MPB
• UDI-Device Identifier: 00801741042065
• UDI-Public: (01)00801741042065
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K030268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2016

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: 5624150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1