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

Lot Number 3340237

Patient Problem Exposure to Body Fluids (1745)

Event Date 02/22/2024

Event Type  malfunction  

Event Description

Blood products leaked on iv tubing set causing employee's direct contact exposure to patient's blood.It is a recurring issue with this product: bd insyte autoguard bc winged shielded iv catheter (lot#3340237) and bd maxzero pressure rated extension set, iv connector.(lot# (10)23109101).Reference report: mw5152235.

• Brand Name: BD INSYTE AUTOGUARD BC WINGED SHIELDED IV CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BD
• MDR Report Key: 18817027
• MDR Text Key: 336822405
• Report Number: MW5152236
• 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: 02/27/2024

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 Lot Number: 3340237
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/29/2024
• Patient Sequence Number: 1