FDA Adverse Event
Other
Summary report: N
BD INSYTE AUTOGUARD SHIELDED IV CATHETER
MDR report key: 1364644
·
Received April 15, 2009
Report
- Report Number
- 1710034-2009-00076
- Event Type
- Other
- Date Received
- April 15, 2009
- Report Date
- March 31, 2009
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS
- Product Code
- FOZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A ROOT CAUSE ANALYSIS COULD NOT BE DETERMINED AS THE SAMPLE WAS NOT AVAILABLE FOR THE INVESTIGATION. THE DEVICE HISTORY COULD NOT BE REVIEWED AS THE LOT NUMBER IS UNKNOWN. CAPA (B) (4) HAS BEEN COMPLETED TO INVESTIGATE THE CAUSES OF GLUE PLACEMENT. QUALITY TRENDING REPORTS PROVIDE EVIDENCE THAT MISPLACED GLUE WAS A CONTRIBUTOR TO THE NON-RETRACTION. THIS CAPA INVESTIGATED THE POTENTIAL CAUSES, REDUCED THE GLUE PLACEMENT DEFECTS AND DOCUMENTED THE SOLUTIONS FOR BETTER MANUFACTURING CONTROL ON THE INSYTE AUTOGUARD LINES. (B) (4)
Description of Event or Problem · 1
NEEDLE FAILED TO RETRACT AND EXTRA CARE WAS NOT EXERCISED, AS THE NURSE DROPPED THE NEEDLE, AND IT STUCK IN HER LEFT KNEE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BD INSYTE AUTOGUARD SHIELDED IV CATHETER | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |