MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWER-TRIALYSIS SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER KIT 13F 15CM TL; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number	5613150
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2018
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 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 of a leak where the catheter meets the hub of the bifurcation was inconclusive due to the sample condition.One 24fr power-trialysis catheter was returned for investigation.The implicated product was a 15cm powertrialysis.The catheter exhibited evidence of use.Blood residue was observed around the rotatable suture wing.The venous and arterial extension legs were discolored.A yellow injection cap, which was not included in the catheter kit, was attached to the blue venous connector.A functional test revealed no leaks in any part of the power-trialysis catheter.The only leak observed was in the yellow injection cap.Fluid was leaking at the interface between the clear threaded portion of the injection cap and the yellow portion of the injection cap.Since the complainant provided a product code for a 15cm catheter and returned a 24cm catheter that didn¿t leak, the complaint was inconclusive.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 line was in less than 24 hours before it was found to be leaking where the catheter meets the hub of the bifurcation.The line was pulled and another 24 cm catheter was placed.The patient references two 24 cm catheters being placed, yet the product information provided for the first/defective device indicates a 15cm catheter; that inconsistency remains as no further clarification has been provided at this time.No patient injury indicated.

• Brand Name: POWER-TRIALYSIS SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER KIT 13F 15CM TL
• 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: 7770625
• Report Number: 3006260740-2018-02024
• Device Sequence Number: 1794262
• Product Code: NIE
• UDI-Device Identifier: 00801741041945
• UDI-Public: (01)00801741041945
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/09/2018

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: 5613150
• Device Catalogue Number: 5613150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 08/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1