FDA Adverse Event
Other
Summary report: N
INSYTE IV CATHETER
MDR report key: 1001467
·
Received February 19, 2008
Report
- Report Number
- 1710034-2008-00015
- Event Type
- Other
- Date Received
- February 19, 2008
- Date of Event
- January 28, 2008
- Report Date
- February 5, 2008
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS
- Product Code
- FOZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ONE USED UNIT WAS REC'D ON 13 FEBRUARY 2008, AND IS CURRENTLY BEING DECONTAMINATED. UPON DECONTAMINATION AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DATE SUBMITTED: 18 FEBRUARY 2008.
Description of Event or Problem · 1
THE CATHETER WAS INSERTED INTO THE HEAD VEIN OF A CHILD. WHEN THE CATHETER WAS REMOVED, THE NURSE NOTICED THAT PART OF THE CATHETER (APPROX 1 CM) WAS MISSING. THE MISSING PART WAS LATER DETECTED IN THE CHILD'S LUNG. ACCORDING TO SALES REP, THE CHILD IS DOING FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSYTE IV CATHETER | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS | NA | 7080622 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |