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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Blood Loss (2597)

Event Date 07/15/2020

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of rect0365 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported the patient male, (b)(6) years old, was admitted to the hospital at 03:55 on (b)(6) 2020 due to "paraquat poisoning", and under local anesthesia at 05:10 according to the doctor's instructions, "right double-lumen catheter placement".Due to the patient's blood vessel, lead to multiple puncture failures, the needle became blunt, and about 7*10cm hematoma appeared at the catheter placement after successful puncture.Immediately applied compression bandage to stop the bleeding and applied ice compress to reduce the swelling.At 10:00, the swelling did not continue to be observed.Continue to observe the changes in the condition according to the doctor's advice.

• 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: kayla olsen ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225010
• MDR Report Key: 10403416
• MDR Text Key: 202804212
• Report Number: 3006260740-2020-02919
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 5593200
• Device Lot Number: RECT0365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 08/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR