MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL / BECTON DICKINSON INFUSION THERAPY SYSTEMS INC BD CATHENA SAFETY IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Lot Number 2215676

Patient Problems Awareness during Anaesthesia (1707); Anxiety (2328)

Event Date 07/03/2023

Event Type  Injury  

Event Description

Patient did not receive intended dose of anesthesia secondary to leakage of piv.This resulted in unintended intraprocedural awareness.No testing performed.Patient emerged from anesthesia anxious and was able to recall specific details during the procedure.Iv assessed and noted to be leaking - towel underneath iv noted to be wet/soaked.

• Brand Name: BD CATHENA SAFETY IV CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON DICKINSON MEDICAL / BECTON DICKINSON INFUSION THERAPY SYSTEMS INC; sandy UT 84070
• MDR Report Key: 17691851
• MDR Text Key: 322923535
• Report Number: MW5145201
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 2215676
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White