FDA Adverse Event
Malfunction
Summary report: N
MEDEX MICRO BORE 72" EXTENSION SET W/ FILTER
MDR report key: 3881261
·
Received February 18, 2014
Report
- Report Number
- 2183502-2014-00037
- Event Type
- Malfunction
- Date Received
- February 18, 2014
- Report Date
- February 17, 2014
- Manufacturer
- SMITHS MEDICAL, INC.
- Product Code
- FPB
- PMA / PMN Number
- K860803
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE COMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.
Description of Event or Problem · 1
A REPORT WAS RECEIVED STATING THAT DURING USE OF THE DEVICE, THE EXTENSION SET TUBING WAS OBSERVED TO BE LEAKING FROM THE FILTER, CAUSING FLUIDS TO LEAK ONTO THE FLOOR AND BLOOD TO BACK UP INTO THE TUBING. THE EXTENSION SET WAS DISCONNECTED AND REPLACED. THERE WERE NO FURTHER ADVERSE EFFECTS TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 100872 | MEDEX MICRO BORE 72" EXTENSION SET W/ FILTER | INTRAVASCULAR ADMIN SET | FPB | SMITHS MEDICAL, INC. | NA | 2561384 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |