FDA Adverse Event
Other
Summary report: N
MILLEX-GS
MDR report key: 2948083
·
Received October 2, 2006
Report
- Report Number
- 1216103-2006-00001
- Event Type
- Other
- Date Received
- October 2, 2006
- Date of Event
- August 1, 2006
- Report Date
- October 2, 2006
- Manufacturer
- MILLIPORE
- Product Code
- FPB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: MILLIPORE IS NOT PLANNING A CORRECTIVE ACTION AT THIS TIME. HOWEVER, A SAMPLE BOX OF MILLIPORE DUALEX PLUS TRANSDUCER PROTECTOR FILTERS (CAT#SLGVS25PS) WAS FORWARDED TO SETON MED CTR FOR EVAL.
Description of Event or Problem · 1
MILLEX-MILLIPORE MEDICAL GRADE, STERILE, 0.22MM FILTER (CAT#SLGSM33SS) IS ALLOWING BLOOD TO PASS THROUGH THE TRANSDUCER OF A KIDNEY DIALYSIS MACHINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MILLEX-GS | STERILIZING SYRINGE FILTER | FPB | MILLIPORE | SLGSM33SS | R6CN48008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |