MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DUOGLIDE SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER 13F FULL PROCEDURE TRAY; BLOOD ACCESS DEVICE AND ACCESSORIES

Catalog Number	5626200
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2016
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 rezh0186 showed no other similar product complaint(s) from this lot number.Device has not yet been returned for evaluation.
Event or Problem Description
As reported by the facility via medwatch, "dr.Was placing temp hd catheter on patient.While attempting to remove the guidewire it was noted the guidewire had unraveled and became flimsy.Wire still connected to tip and removed completely.No harm to patient.".

• Brand Name: DUOGLIDE SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER 13F FULL PROCEDURE TRAY
• 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: 6045418
• Report Number: 3006260740-2016-00555
• Device Sequence Number: 961827
• Product Code: MPB
• UDI-Device Identifier: 00801741042157
• UDI-Public: (01)00801741042157(17)170128(10)REZH0186
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K030268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/26/2016
• Report Date (Section F): 09/14/2016

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 Expiration Date: 01/28/2017
• Device Catalogue Number: 5626200
• Device Lot Number: REZH0186
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/05/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 81
• Date Report Sent to FDA: 09/14/2016