MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWER-TRIALYSIS SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER FULL PROCEDURE; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number 5615150

Device Problem Complete Blockage (1094)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.-see: [medwatch-mw5078408 -#1211062.Pdf].

Event Description

It was reported via medwatch description that the "dialysis catheter was being exchanged because it had clotted off.When removing the catheter a bulge was noted in the blue lumen line.It appears to be a weak point in the catheter lumen.Potential for massive bleeding if line had ruptured.".

• Brand Name: POWER-TRIALYSIS SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER FULL PROCEDURE
• Type of Device: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 7807809
• MDR Text Key: 118111926
• Report Number: 3006260740-2018-02180
• Device Sequence Number: 1
• Product Code: NIE
• UDI-Device Identifier: 00801741075094
• UDI-Public: (01)00801741075094
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/11/2018,08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5615150
• Device Catalogue Number: 5615150
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/11/2018
• Distributor Facility Aware Date: 06/16/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1