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

Patient Problems Hemorrhage/Bleeding (1888); Failure of Implant (1924); Needle Stick/Puncture (2462)

Event Date 09/08/2023

Event Type  malfunction  

Event Description

After inserting the angiocath, i pressed the white button on the angiocath, but it did not retract the needle from the vein causing the valve to remain open, allowing a small amount of blood to spill onto the blanket and floor.I had to completely remove the angiocath, bandage the site, and restart with a new angiocath on a different location on the patient.Bd insyte autoguard bc.(b)(4).

• Brand Name: BD INSYTE AUTOGUARD BC
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BD
• MDR Report Key: 17745593
• MDR Text Key: 323532233
• Report Number: MW5145643
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/13/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White