MAUDE Adverse Event Report: BD/BARD ACCESS SYSTEMS, INC. POWER LOC NEEDLE WITH Y-SITE 22G 3/4 IN PORT NEEDLE; SET, ADMINISTRATION, INTRAVASCULAR

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

Patient Problem Pain (1994)

Event Date 05/08/2023

Event Type  malfunction  

Event Description

Ivf infusing through her port.Called to the room because parents noted blood leaking from her tubing.Soft tubing just before the distal leur (just before where soft tubing connects to hard plastic) found to have crack noted during infusion.This opened up central line to infection and necessitated needle removal and reinsertion (painful in child).

• Brand Name: POWER LOC NEEDLE WITH Y-SITE 22G 3/4 IN PORT NEEDLE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD/BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 17108525
• MDR Text Key: 317127576
• Report Number: MW5118320
• 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: 06/06/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 16 MO
• Patient Sex: Female
• Patient Weight: 10 KG
• Patient Ethnicity: Non Hispanic