FDA Adverse Event
Malfunction
Summary report: N
HUDSON SPIRAL-FLEX ET TUBE 7.0
MDR report key: 1993686
·
Received January 6, 2011
Report
- Report Number
- 3003898360-2011-00015
- Event Type
- Malfunction
- Date Received
- January 6, 2011
- Report Date
- December 9, 2010
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- BTR
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PRODUCT WAS NOT RECEIVED BY MFR FOR EVAL AT THIS TIME. INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: IT WAS NOTICED WHEN THE DRAPES WERE REMOVED THAT THE PILOT BALLOON WAS DETACHED. THE PT HAD TO BE REINTUBATED. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON SPIRAL-FLEX ET TUBE 7.0 | SPIRAL-FLEX ET TUBE | BTR | TELEFLEX MEDICAL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |