FDA Adverse Event
Malfunction
Summary report: N
MISTY NEB W/AEROSOL MASK 50/CS
MDR report key: 2973066
·
Received February 21, 2013
Report
- Report Number
- 8030673-2013-00017
- Event Type
- Malfunction
- Date Received
- February 21, 2013
- Date of Event
- February 20, 2013
- Report Date
- February 20, 2013
- Manufacturer
- CAREFUSION
- Product Code
- CAF
- PMA / PMN Number
- K883964
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). FURTHER CLARIFICATION FROM THE MANUFACTURING PLANT CONFIRMED THAT THERE WAS NO ADDITIONAL OCCLUDED PRODUCT DISCOVERED UPON SAMPLE RETURN. THIS COMPLAINT WILL BE CLOSED.
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE HAS BEEN RECEIVED AND IS THE PROCESS OF BEING EVALUATED. UPON COMPLETION OF CAREFUSION'S INVESTIGATION, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.
Description of Event or Problem · 1
MANUFACTURING PLANT CONFIRMED THAT UPON SAMPLE RETURN, AN ADDITIONAL OCCLUDED NEBULIZER WAS DISCOVERED. NO PATIENT IMPACT, DISCOVERED PRIOR TO USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 76770 | MISTY NEB W/AEROSOL MASK 50/CS | NEBULIZER (DIRECT PATIENT INTERFACE) | CAF | CAREFUSION | 008299-A | 0000462990 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |