FDA Adverse Event
Malfunction
Summary report: N
FILTERLINE H SET INF/NEO
MDR report key: 2069430
·
Received March 28, 2011
Report
- Report Number
- 8044004-2011-00001
- Event Type
- Malfunction
- Date Received
- March 28, 2011
- Date of Event
- March 11, 2011
- Report Date
- March 26, 2011
- Manufacturer
- ORIDION MEDICAL 1987 LTD.
- Product Code
- CCK
- PMA / PMN Number
- K980327
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ORIDION PLANS TO SUBMIT A CORRECTION AND REMOVAL REPORT TO THE AGENCY SHORTLY.
Description of Event or Problem · 1
DURING INCOMING INSPECTION PERFORMED BY A DISTRIBUTOR PLASTIC STRANDS WITH A TYPICAL LENGTH OF 0.5 CM AND DIAMETER OF 100 MICRONS WERE FOUND INSIDE INFANT NEONATAL AIRWAY ADAPTORS WHICH ARE PART OF FILTERLINE H INFANT NEONATAL CO2 SAMPLING LINE SETS, PROTRUDING FROM THE PLASTIC SURFACE. NO RELATED COMPLAINTS HAVE BEEN RECEIVED FROM ANY END USERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FILTERLINE H SET INF/NEO | CCK - CO2 GAS ANALYZER | CCK | ORIDION MEDICAL 1987 LTD. | 006324 | M8555B11 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |