MAUDE Adverse Event Report: UNKNOWN ARTERIAL BLOOD SAMPLING KIT

Device Problems Leak/Splash (1354); Unsealed Device Packaging (1444)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  malfunction  

Event Description

A user facility biomed technician reported that during a patient treatment blood back flowed through the heparin syringe and out the plunger.Upon follow up with the biomed, it was confirmed that the blood loss was caused by a defective seal between the plunger and the heparin syringe.It was confirmed the estimate blood loss was 5ml, and it was confirmed the patient stayed on the same machine to complete treatment with no injury, adverse event, or medical intervention.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ARTERIAL BLOOD SAMPLING KIT
• Type of Device: ARTERIAL BLOOD SAMPLING KIT
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17516416
• MDR Text Key: 321057436
• Report Number: MW5123365
• Device Sequence Number: 1
• Product Code: CBT
• 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: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1