FDA Adverse Event
Malfunction
Summary report: N
SUPERSET CATHETER MOUNT
MDR report key: 1051176
·
Received May 22, 2008
Report
- Report Number
- 1319447-2008-00001
- Event Type
- Malfunction
- Date Received
- May 22, 2008
- Date of Event
- February 1, 2008
- Report Date
- May 12, 2008
- Manufacturer
- INTERSURGICAL INCORPORATED
- Product Code
- BZA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PRODUCT LABEL STATES: WHEN ASSEMBLING ANY CONNECTORS USE A PUSH AND TWIST ACTION TO ENSURE A SECURE FIT.
Description of Event or Problem · 1
CONNECTOR FELL OFF TRACH TUBE DURING USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUPERSET CATHETER MOUNT | CONNECTOR, AIRWAY (EXTENSION) | BZA | INTERSURGICAL INCORPORATED | 3512 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |