FDA Adverse Event
Other
Summary report: N
BRONCHO-CATH ENDOBRONCHEAL TUBE, LEFT SIDED, 37 FR.
MDR report key: 84524
·
Received April 14, 1997
Report
- Report Number
- 9681384-1997-00032
- Event Type
- Other
- Date Received
- April 14, 1997
- Date of Event
- March 11, 1997
- Report Date
- April 11, 1997
- Manufacturer
- MALLINCKRODT MEDICAL, INC.
- Product Code
- CBI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
HOSP REPORTED THAT THERE WAS A CUFF INFLATION LEAK. NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BRONCHO-CATH ENDOBRONCHEAL TUBE, LEFT SIDED, 37 FR. | ENDOBRONCHEAL TUBE, LEFT SIDED, 37FR. | CBI | MALLINCKRODT MEDICAL, INC. | NA | 1996-12 4153 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Other |