MAUDE Adverse Event Report: BD / CAREFUSION 303, INC. BD SYRINGE LOW SORBING ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Backflow (1064); Disconnection (1171)

Patient Problem Insufficient Information (4580)

Event Date 11/16/2021

Event Type  malfunction  

Event Description

Bd syringe low sorbing administration set with pressure sensing disc connected to both infant and pump.When i went to re-trace the line, i noticed the pressure disk was in the sensor, but the tubing was disconnected from the disk right below the disk.Blood did back-flow from infant into the entire tubing.Malfunctioned tubing removed and replaced with a new set up.

• Brand Name: BD SYRINGE LOW SORBING ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD / CAREFUSION 303, INC.
• MDR Report Key: 12961165
• MDR Text Key: 282038924
• Report Number: MW5105919
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 1 DA
• Patient Sex: Male
• Patient Weight: 1 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian