MAUDE Adverse Event Report: BD MAXZERO NEEDLESS CONNECTOR; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Lot Number 24025568

Patient Problem Exposure to Body Fluids (1745)

Event Date 03/21/2024

Event Type  malfunction  

Event Description

Rn administering blood products was discontinuing the infusion and when unhooking the tubing blood forcefully expelled from the one-way valve onto the rn arm.This product was recently changed to a new bd valve and the rep was on the unit and was surprised of the finding and stated this should not happen.Bd maxzero needless connector lot (10)24025568.

• Brand Name: MAXZERO NEEDLESS CONNECTOR
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BD
• MDR Report Key: 19003705
• MDR Text Key: 339059662
• Report Number: MW5153353
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 24025568
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White