MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. CATHETER IV IAG STEILE YLW 24.75 CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number 381412-TPMECC

Device Problems Fluid Leak (1250); Material Puncture/Hole (1504)

Patient Problem Insufficient Information (4580)

Event Date 10/24/2021

Event Type  malfunction  

Event Description

Rn was inserting a 24 gu iv when the catheter was noted to have a hole in it. It was noted with flushing as the iv fluid came out of the other side of the catheter. Fda safety report id# (b)(4).

• Brand Name: CATHETER IV IAG STEILE YLW 24.75
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
• MDR Report Key: 12738033
• MDR Text Key: 280054100
• Report Number: MW5105072
• Device Sequence Number: 1
• Product Code: FOZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 10/29/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 381412-TPMECC
• Device Lot Number: 0279765
• Was Device Available for Evaluation?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage