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

Model Number 382523

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/11/2022

Event Type  malfunction  

Event Description

Leakage was noted at the connection point of bd angiocath 22g and the one-link catheter extension set.Rn noted leaking at the site of the connection at the time of iv insertion, during flushing.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): BECTON, DICKINSON AND COMPANY
• MDR Report Key: 15233331
• MDR Text Key: 298073657
• Report Number: MW5111475
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 08/11/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 382523
• Device Catalogue Number: 382523
• Device Lot Number: 2021886
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 64 KG