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

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/04/2018
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rebx1981 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the user inserted the wire and the catheter.It was stated that when trying to pull the wire out it was not possible because the wire got caught in the catheter.No other information was provided.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint that the guidewire was caught in the catheter was confirmed and the cause appeared to be associated with use of the device.One 20cm trialysis catheter was returned for investigation.The catheter was received with the guidewire in the power injectable lumen.The guidewire extended from each end of the catheter.The section of coil wire proximal to the connector was stretched and unraveled over the core wires.The section of coil wire distal to the catheter tip was tightly coiled.The weld tips were visible at each end of the guidewire.A tactual investigation revealed that the coil wire would stretch over the core wires.After forcefully removing the guidewire from the catheter, biological residue was found on the section of guidewire that was within the catheter.The residue most likely caused the guidewire to lodge within the catheter.The outside diameter (od) of the guidewire was measured with calipers and was found to be within specification.The returned trialysis catheter revealed no obstructions in the lumen.Resistance was not observed when passing an unused 0.035¿ guidewire through the power injectable lumen.A lot history review (lhr) of rebx1981 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the user inserted the wire and the catheter.It was stated that when trying to pull the wire out it was not possible because the wire got caught in the catheter.No other information was provided.

• Brand Name: POWER-TRIALYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER KIT 13F BASIC KIT (T/L)
• 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: 7308232
• Report Number: 3006260740-2018-00323
• Device Sequence Number: 2249432
• Product Code: NIE
• UDI-Device Identifier: 00801741041907
• UDI-Public: (01)00801741041907
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K133456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2018

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: N/A
• Device Catalogue Number: 5608200
• Device Lot Number: REBX1981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Initial Date Received by Manufacturer: 02/07/2018
• Supplement Date Received by Manufacturer: 03/21/2018
• Initial Report FDA Received Date: 03/01/2018
• Supplement Report FDA Received Date: 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1