MAUDE Adverse Event Report: UNKNOWN SINGLE NEEDLE ( CO - AXIAL FLOW) DIALYSIS KIT; SINGLE NEEDLE (CO-AXIAL FLOW) DIALYSIS KIT

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Event Description

A biomedical technician reported that during a patient hemodialysis (hd) treatment, the patient accidently pulled the needle a 15 gauge from her venous side, and the needle dislodged form patient's harm.The patient care technician (pct) stated that the patient had twenty four minutes left in treatment and they opted to end treatment at the time.The patient's estimated blood loss (ebl) from the venous side was approximately 150 ml.The pct stated that patient was rinsed back with saline (unknown amount) through the arterial line.The patient did not develop any symptoms, injuries, or required medical intervention due to this incident.The manufacturer of the needle is unknown as the additional information was requested; however not provided.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SINGLE NEEDLE ( CO - AXIAL FLOW) DIALYSIS KIT
• Type of Device: SINGLE NEEDLE (CO-AXIAL FLOW) DIALYSIS KIT
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17532667
• MDR Text Key: 321144314
• Report Number: MW5139574
• Device Sequence Number: 1
• Product Code: PPL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1