MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER, ALPHACURVE, 14.5F STANDARD KIT (19CM); CATHETER, HEMODIALYSIS, IMPLANTED

Model Number N/A

Device Problems Device Operates Differently Than Expected (2913); No Flow (2991)

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) of reya1916 showed no other similar product complaint(s) from this lot number.Device has not be returned for evaluation.

Event Description

It was reported that soon after the procedure was completed, the tube started to provide no flow coming during dialysis.It was stated the valve was not working and was not blocking the blood.Upon further examination the facility concluded that "the tube in itself is faulty and needs a replacement".

• Brand Name: HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER, ALPHACURVE, 14.5F STANDARD KIT (19CM)
• Type of Device: CATHETER, HEMODIALYSIS, 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: shelly gilbert ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225640
• MDR Report Key: 6955982
• MDR Text Key: 89614753
• Report Number: 3006260740-2017-01838
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741013171
• UDI-Public: (01)00801741013171
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K030020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 5735150
• Device Lot Number: REYA1916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2016
• 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