FDA Adverse Event
Malfunction
Summary report: N
BD INTIMA IV CATHETER
MDR report key: 851690
·
Received May 16, 2007
Report
- Report Number
- 9610847-2007-00048
- Event Type
- Malfunction
- Date Received
- May 16, 2007
- Report Date
- May 4, 2007
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS
- Product Code
- FOZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE ACTUAL SAMPLE INVOLVED IN THIS INCIDENT IS NOT AVAILABLE FOR EVALUATION. HOWEVER, REPRESENTATIVE UNITS FROM REPORTED LOT NUMBER 6122603 WILL BE SENT FOR INVESTIGATION. ATTEMPTS ARE BEING MADE TO RETRIEVE ADDITIONAL INFORMATION REGARDING THIS INCIDENT. UPON RECEIPT OF THE SAMPLES AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
DURING THE INFUSION, THE CATHETER DISCONNECTED FROM THE CANNULA AND WING, SO THE OPERATOR WAS STAINED WITH BLOOD ON HIS GLOVE. THE CUSTOMER COULD NOT REMEMBER IF THE SEPARATION OCCURRED AT THE CATHETER/INSERTER OR THE INSERTER/ EXTENSION TUBING. NO HARM TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BD INTIMA IV CATHETER | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS | NA | 6122603 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |