FDA Adverse Event
Other
Summary report: N
PALL BB50T BREATHING CIRCUIT FILTER
MDR report key: 101433
·
Received June 30, 1997
Report
- Report Number
- 2647898-1997-00006
- Event Type
- Other
- Date Received
- June 30, 1997
- Date of Event
- May 21, 1997
- Report Date
- June 6, 1997
- Manufacturer
- PALL BIOMEDICAL INC.
- Product Code
- CAH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- RESPIRATORY THERAPIST
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS MOUNTED ON THE EXPIRATORY END AT 5 P.M., AND IT WAS FOUND THAT THE AIRWAY PRESSURE WENT UP TO 30-40 CM OF H20 AT 8 A.M. THE NEXT MORNING. THE PT COULD NOT EXPIRE, PRESSURE DROPPED DOWN AFTER THE REMOVAL OF THE DEVICE. NO OBSTRUCTION WAS OBSERVED IN THE CIRCUIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PALL BB50T BREATHING CIRCUIT FILTER | BREATHING CIRCUIT FILTER | CAH | PALL BIOMEDICAL INC. | BB50T | 703704 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention | 2 ML BRICANYL DILUTED 4 ML FOR ONE TIME THERAPY.| AND 2 ML OF BRICANYL DILUTED INTO 4 ML| BRICANYL (TERBUTALINE SULPHATE) Q6HR 2.5 MG/ML| FOR ONE TIME THERAPY. |