MAUDE Adverse Event Report: OWENS & MINOR DISTRIBUTION, INC. MEDICHOICE BLOOD TRANSFER DEVICE WITH MALE LUER LOCK; SYSTEM, BLOOD COLLECTION, VACUUM-ASSISTED, MANUAL

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/20/2024

Event Type  malfunction  

Event Description

I was drawing blood from the patient's arterial line with a blood transfer device.After the green tube was full i pulled it out and reached for the next tube, just as i was doing this blood started spraying up into the air and showered down on my patient's abdomen.I do not believe that i was sprayed with blood.Very unsafe condition! i addressed this with my charge nurse and it was not the first time that she heard/seen that happen.

• Brand Name: MEDICHOICE BLOOD TRANSFER DEVICE WITH MALE LUER LOCK
• Type of Device: SYSTEM, BLOOD COLLECTION, VACUUM-ASSISTED, MANUAL
• Manufacturer (Section D): OWENS & MINOR DISTRIBUTION, INC.; 9120 lockwood blvd; mechanicsville VA 23116
• MDR Report Key: 18739901
• MDR Text Key: 335865055
• Report Number: MW5151773
• Device Sequence Number: 1
• Product Code: KST
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THERAPY START AND END DATE:
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 107 KG
• Patient Ethnicity: Hispanic
• Patient Race: White