MAUDE Adverse Event Report: BECTOR DICKINSON INFUSION THERAPY SYSTEMS, INC. BD INSYTE AUTOGUARD BC; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number 382533

Device Problems Material Separation (1562); Positioning Problem (3009); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Attempting to insert iv into vein while advancing iv catheter the vein began to curl.I then withdrew the iv and noticed the catheter was separated from the iv sideways.Fda safety report id # (b)(4).

• Brand Name: BD INSYTE AUTOGUARD BC
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTOR DICKINSON INFUSION THERAPY SYSTEMS, INC.; sandy UT 84070
• MDR Report Key: 15563028
• MDR Text Key: 301559255
• Report Number: MW5112496
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903825332
• UDI-Public: (01)00382903825332
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/05/2022

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 Model Number: 382533
• Device Catalogue Number: 382533
• Device Lot Number: 2235214
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1