FDA Adverse Event
Other
Summary report: N
AEROSOL TEE CONNECTOR
MDR report key: 871484
·
Received March 13, 2007
Report
- Report Number
- 3004365956-2007-00010
- Event Type
- Other
- Date Received
- March 13, 2007
- Report Date
- March 9, 2007
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- BZA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
AT THIS TIME, THE SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. SHOULD THE SAMPLE BE RETURNED FROM THE USER FACILITY, A FULL INVESTIGATION WILL BE PERFORMED.
Description of Event or Problem · 1
IT WAS REPORTED ON 03/09/2007 THAT AN INCIDENT INVOLVING AN AEROSOL TEE CONNECTOR OCCURRED DURING USE ON A PATIENT. TWO PIECES BROKE OFF FROM THE AEROSOL TEE AND ENTERED THE PATIENT'S MOUTH. THE HOSPITAL STAFF REMOVED THE PIECES WITHOUT INCIDENT. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AEROSOL TEE CONNECTOR | CONNECTOR/ADAPTOR | BZA | TELEFLEX MEDICAL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Other |