MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 NIAGARA DIALYSIS CATHETER KIT 13.5F X 15CM; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem Hematoma (1884)

Event Date 06/16/2022

Event Type  Injury  

Event Description

It was reported that when the catheter was paused, under ultrasound, the doctor had difficulty introducing the catheter into the jugular despite correct dilation.He used another catheter from the same lot, the patient has a jugular hematoma.Both devices were discarded after event.Additional information received 7/11/22: it was reported by healthcare professional ¿the hematoma occurred when the kit was attempted despite placement under echo and optimal dilation with, i think, a kit that had to go partly subcutaneously.So the hematoma is consecutive to the installation of the kit and prevented the installation of another kit in the same place.It was reported this occurred with two devices.This report addresses the first device.

Manufacturer Narrative

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.A lot history review (lhr) of refx3191 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility in france.Device not returned.

• Brand Name: NIAGARA DIALYSIS CATHETER KIT 13.5F X 15CM
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15136150
• MDR Text Key: 296948667
• Report Number: 3006260740-2022-02975
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801741045608
• UDI-Public: (01)00801741045608
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K090102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 5594150
• Device Lot Number: REFX3191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• 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 Sex: Female