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

Model Number AV 1625 HTC 15R GT

Device Problems Leak/Splash (1354); Device Dislodged or Dislocated (2923)

Patient Problems Shock (2072); Blood Loss (2597)

Event Date 11/25/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Patient was connected to the dialysis machine at 12:43.About an hour and 10 minutes into the treatment, the nurse noticed that the venous needle came out of the patient's fistula/access, and as a result, blood was squirting from the needle, upwards.According to the nurse who was present at the time of the event, there were no problems when inserting the needle into the patient's fistula/access, and there were no abnormalities observed in the arterial venous fistula needle.According to the staff, there was no alert / alarm from the dialysis machine and the blood pump segment did not stop automatically.The nurse had to stop the pump manually.The patient lost about 300ml of blood during the incident, and there was a change in the patient's consciousness.The bleeding was stopped by the staff.Vital signs were taken, all normal.Patient was examined and was treated according to medical instructions.She was given fluids and a blood does.The patient was then transferred to a different machine to complete the dialysis treatment.Once the treatment was completed, she was sent to the er for supervision, then discharged home.Pump speed during treatment: 280 ml/min.Other devices used: surdial x dialysis machine.

• 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 107 avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 9500530
• MDR Text Key: 174848219
• Report Number: 8041145-2019-00018
• Device Sequence Number: 1
• Product Code: FIE
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K955182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/19/2019

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: 02/29/2024
• Device Model Number: AV 1625 HTC 15R GT
• Device Lot Number: 19C25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention