MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWER-TRIALYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER 13 F (15CM) (TRIPLE-LUMEN); 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 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 following were reviewed as part of this investigation: patient severity, trend 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 stuck inside the catheter was confirmed, and the cause appears to be manufacturing related.One trialysis catheter was returned for investigation.The catheter showed no evidence of use.The proximal end of a 0.035¿ guidewire was inserted into the distal tip of the catheter.The guidewire was advanced up to the trifurcation before resistance was noted.The catheter was cut perpendicular to the axis of the tubing at the distal end of the trifurcation, which revealed narrowing of the catheter lumen within the distal tip of the trifurcation.It appears that blow down from the molding process of the trifurcation filled a portion of the lumen.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 by risk management that during insertion of the catheter, the guidewire was stuck together.Another kit was opened and used to complete the procedure.No other information was available.No patient harm was reported.

• Brand Name: POWER-TRIALYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER 13 F (15CM) (TRIPLE-LUMEN)
• 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: 6440568
• Report Number: 3006260740-2017-00319
• Device Sequence Number: 621828
• Product Code: NIE
• UDI-Device Identifier: 00801741086953
• UDI-Public: (01)00801741086953
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K133456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2017

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: 5605150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2017
• Initial Report FDA Received Date: 03/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1