MAUDE Adverse Event Report: NIPRO (THAILAND) CORP. LTD. NIPRO STANDARD AVF NEEDLE

Model Number AVF 16GX1" TC-15W

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problems Dyspnea (1816); Nausea (1970)

Event Date 02/12/2022

Event Type  Injury  

Event Description

After starting dialysis, patient reports feeling nauseous, but with stable vital functions and baseline saturation.Capillary blood glucose 140 mg/dl.This symptomatology was increasing in intensity, patient felt a sensation of dyspnea without hyposaturation.Dialysis was immediately interrupted and the patient was disconnected without returning the blood from the circuit.Other devices used: sureflux-21ux, lot 21f10d.

Event Description

After starting dialysis, patient reports feeling nauseous, but with stable vital functions and baseline saturation.Capillary blood glucose 140 mg/dl.This symptomatology was increasing in intensity, patient felt a sensation of dyspnea without hyposaturation.Dialysis was immediately interrupted and the patient was disconnected without returning the blood from the circuit.Other devices used: sureflux-21ux, lot 21f10d.Additional details: during the event, the tas (systolic blood pressure) lowered to 100 mmhg, staff administered 300ml ssf (saline solution).Oxygen therapy was administered via nasal cannula at 31pm with 100% saturation.Capillary glycemia of 130mg/dl and staff administered urbason 80mg total and polaramine in bolus.Patient had an ekg done and sinus rythm results were 65bpm without alterations in repolarization.Patient recovered without further issues.

• Brand Name: NIPRO STANDARD AVF NEEDLE
• Type of Device: AVF NEEDLE
• Manufacturer (Section D): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8; bangnomko,; sena, ayuthaya 13110 ,; TH 13110,
• Manufacturer (Section G): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8; bangnomko,; sena, ayuthaya 13110 ,; TH 13110,
• Manufacturer Contact: michelle tejada ; 3150 nw 107th avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 13828711
• MDR Text Key: 292592158
• Report Number: 8041145-2022-00001
• Device Sequence Number: 1
• Product Code: FIE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K955182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2022

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 Model Number: AVF 16GX1" TC-15W
• Device Catalogue Number: 5088651
• Device Lot Number: CNNC102 AND CNND123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2022
• Initial Date FDA Received: 03/20/2022
• Supplement Dates Manufacturer Received: 02/25/2022
• Supplement Dates FDA Received: 03/28/2022
• 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): Other; Required Intervention