MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 NIAGARA DIALYSIS CATHETER KIT 13.5F X 24CM (SHORT-TERM) (DUAL-LUMEN); CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number N/A

Device Problem Component Incompatible (1108)

Patient Problem Hematoma (1884)

Event Date 07/26/2023

Event Type  Injury  

Event Description

It was reported, "on (b)(6) 2023 a right femoral dialysis catheter was inserted in the patient.Difficult insertion as there was a problem inserting the guide.Instructions to monitor the catheter during dialysis: no worries found dialysis effective/patient deglobulates transfusion/ but on (b)(6) 2023 appearance of a hematoma in the thigh scanner shows a retroperitoneal collection.Resulted in bodily injury, material damage, psychological damage, material waste, dissatisfaction, loss of time.".

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.H3 other text : device not returned for evaluation.

• Brand Name: NIAGARA DIALYSIS CATHETER KIT 13.5F X 24CM (SHORT-TERM) (DUAL-LUMEN)
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17597389
• MDR Text Key: 321672615
• Report Number: 3006260740-2023-03628
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801741045585
• UDI-Public: (01)00801741045585
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K030268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 08/04/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 5593240
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2023
• Initial Date FDA Received: 08/22/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR