FDA Adverse Event
Malfunction
Summary report: N
22G BD INSYTE AUTOGUARD WINGED ; 22GX1 INCH
MDR report key: 1800164
·
Received July 28, 2010
Report
- Report Number
- 1800164
- Event Type
- Malfunction
- Date Received
- July 28, 2010
- Date of Event
- June 16, 2010
- Report Date
- July 23, 2010
- Manufacturer
- BD MEDICAL
- Product Code
- FOZ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
PATIENT REQUIRED PERIPHERAL INTRAVENOUS (PIV) START. PIV INITIATED WITH 22G CATHETER IN LEFT (ANTECUBITAL) AC. APPROXIMATELY 10 SECONDS FOLLOWING INITIAL POKE, THE RN NOTED SMALL AMOUNT OF BLOOD IN VERY BOTTOM PART OF SPRING AREA WITH NO FLASH NOTED ANYWHERE ELSE. DESPITE CLOSE MONITORING OF CATHETER NO BLOOD WAS NOTED TO HAVE RETURNED. NO OTHER FLASH NOTED. UNABLE TO ADVANCE CATHETER INTO VEIN. CATHETER REMOVED AND SMALL AMOUNT OF BLOOD WAS THEN NOTED ON TIP OF CATHETER. PIV ABLE TO BE ESTABLISHED WITH NEW CATHETER IN RIGHT AC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 22G BD INSYTE AUTOGUARD WINGED ; 22GX1 INCH | 22G BD INSYTE AUTOGUARD WINGED ; 22GX1 INCH | FOZ | BD MEDICAL | N/A | 0057163 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR |