MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NIAGARA DIALYSIS CATHETER KIT 13.5F X 20CM (SHORT-TERM) (DUAL-LUMEN); CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 06/09/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of redw0139 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported the patient (b)(6) had a blood creatinine of 1025umol/l he was admitted to the hospital on (b)(6) 2020 due to diabetic nephropathy and uremia.Hemodialysis was scheduled for temporary femoral vein catheterization on the same day.When using bard's double lumen, unpack the package and find that the tip of the catheter is bent, straighten the tip and use it again.The effect is not good, and the guide wire cannot be inserted even if it is bent.Then, a set of double-lumen catheter guide wire was replaced without bending and successfully placed.No adverse effects on patients.

Manufacturer Narrative

H11:section a through f - the information provided by bd 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 bd.The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of redw0139 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported the patient, male, 70 years old, had a blood creatinine of 1025umol/l.He was admitted to the hospital on (b)(6) 2020 due to diabetic nephropathy and uremia.Hemodialysis was scheduled for temporary femoral vein catheterization on the same day.When using bard's double lumen, unpack the package and find that the tip of the catheter is bent, straighten the tip and use it again.The effect is not good, and the guide wire cannot be inserted even if it is bent.Then, a set of double-lumen catheter guide wire was replaced without bending and successfully placed.No adverse effects on patients.

• Brand Name: NIAGARA DIALYSIS CATHETER KIT 13.5F X 20CM (SHORT-TERM) (DUAL-LUMEN)
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10279409
• MDR Text Key: 200515645
• Report Number: 3006260740-2020-02424
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801741045578
• UDI-Public: (01)00801741045578
• Combination Product (y/n): N
• PMA/PMN Number: K030268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 5593200
• Device Lot Number: REDW0139
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/24/2020
• Initial Date FDA Received: 07/15/2020
• Supplement Dates Manufacturer Received: 06/24/2020
• Supplement Dates FDA Received: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR