FDA Adverse Event
Other
Summary report: N
BD INSYTE AUTOGUARD SHIELDED IV CATHETER
MDR report key: 1385941
·
Received May 14, 2009
Report
- Report Number
- 1710034-2009-00084
- Event Type
- Other
- Date Received
- May 14, 2009
- Date of Event
- April 13, 2009
- Report Date
- April 15, 2009
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS
- Product Code
- FOZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER INDICATED THE SAMPLE WOULD BE SENT IN FOR THE INVESTIGATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4)
Description of Event or Problem · 1
WHEN THE NURSE INSERTED THE CATHETER INTO THE VEIN AND RETRACTED THE NEEDLE, THE CATHETER DISCONNECTED FROM THE HUB. THE PATIENT WAS REQUIRED TO STAY TWO EXTRA DAYS IN THE HOSPITAL FROM THIS EVENT.
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 | 7340858 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization| O |