MAUDE Adverse Event Report: BECTON DICKINSON 22G BD INSYTE AUTOGUARD BC; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Device Problems Retraction Problem (1536); Device Dislodged or Dislocated (2923); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

One 22g bd insyte autoguard bc was bent and not used on the patient.Two others did not retract the needle correctly.Instead, when the rn hit the retract button, it pulled out both the needle and the plastic catheter that normally sits in the vein.Fda safety report id# (b)(4).

• Brand Name: 22G BD INSYTE AUTOGUARD BC
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON DICKINSON
• MDR Report Key: 11385019
• MDR Text Key: 234041800
• Report Number: MW5099653
• Device Sequence Number: 3
• Product Code: FOZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/24/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1