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

Model Number 381444

Device Problems Retraction Problem (1536); Device Fell (4014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/09/2019

Event Type  malfunction  

Event Description

Iv placed and upon pressing the needle recoil button, to retract the needle and allow advancement of the plastic cannula, the green hub of the abbocath fell on the chux.Immediate intervention provided to ensure that no adverse event occurred with the plastic cannula, which was believed to be in the vein.Upon further inspection of the device, the plastic cannula was found adhered to the needle of the abbocath.No adverse reaction or additional; patient care needed.All parts of the bd insyte autoguard were accounted for.Fda safety report id # (b)(4).

• Brand Name: BD INSYTE AUTOGUARD
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM, LESS THAN 30 DAYS
• Manufacturer (Section D): BD
• MDR Report Key: 9516458
• MDR Text Key: 172909346
• Report Number: MW5091869
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 381444
• Device Catalogue Number: 381444
• Was Device Available for Evaluation?: Yes
• 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
• Patient Outcome(s): Other
• Patient Age: 89 YR