MAUDE Adverse Event Report: BD BD SINGLE LUMEN; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/22/2023

Event Type  Injury  

Event Description

Pt found to have blood-saturated linens near broviac central line tubing.Rn clamped and assessed central line.Rn flushed bifuse attached to lumen backing up blood, noticing where the clave and bifuse lumen were connected was cracked (leaking fluid out).Cn and md notified, rn flushed line, clamped and changed bifuse out.Line now appropriately working again.Approximately 33mls of blood lost.Infant received 43 ml of prbc's after incident.

• Brand Name: BD SINGLE LUMEN
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD
• MDR Report Key: 16461846
• MDR Text Key: 310609371
• Report Number: MW5115333
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 MO
• Patient Sex: Male
• Patient Weight: 3 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White