MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE 18GA ANGIOCATHETER AUTOGUARD BC PRO; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number 392644

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/16/2022

Event Type  malfunction  

Event Description

Bd 18ga angiocatheter stocked in ems storeroom was found to be cracked at the open end of the hub, patient was stuck and then blood could not be controlled coming from the hub; crack was identified.Patient had to be stuck again.Lot number 1103755.Fda safety report id #(b)(4).

• Brand Name: BD INSYTE 18GA ANGIOCATHETER AUTOGUARD BC PRO
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; sandy UT 84070
• MDR Report Key: 15885850
• MDR Text Key: 304636539
• Report Number: MW5113523
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 11/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 392644
• Device Catalogue Number: 392644
• Device Lot Number: 1103755
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1