FDA Adverse Event
Other
Summary report: N
BD INSYTE AUTOGUARD SHIELDED IV CATHETER
MDR report key: 893011
·
Received August 9, 2007
Report
- Report Number
- 1710034-2007-00074
- Event Type
- Other
- Date Received
- August 9, 2007
- Date of Event
- July 20, 2007
- Report Date
- July 26, 2007
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
- Product Code
- FOZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
CONCLUSIONS- A ROOT CAUSE ANALYSIS COULD NOT BE PERFORMED AS THE SAMPLE HAD BEEN DISCARDED BY THE HOSPITAL, AND THEREFORE, WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY WAS REVIEWED FOR REPORTED LOT NUMBER 7080915 AND NO IRREGULARITIES WERE NOTED DURING THE LOT'S MANUFACTURE.
Description of Event or Problem · 1
THE NURSE REPORTED A VERY DIFFICULT STICK. THE CATHETER TIP SHEARED WHILE INSIDE THE PATIENT. THE CATHETER TIP WAS ABLE TO BE RETRIEVED FROM THE BABY WITHOUT SURGICAL INTERVENTION. NO EXTRA HOSPITALIZATION WAS NECESSARY, AND THERE WAS NO HARM TO THE PATIENT.
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, INC. | NA | 7080915 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other |