FDA Adverse Event
Malfunction
Summary report: N
HUDSON HVT ISIS ENDOTRACHEAL CUFF TUBE
MDR report key: 2171434
·
Received June 29, 2011
Report
- Report Number
- 3003898360-2011-00296
- Event Type
- Malfunction
- Date Received
- June 29, 2011
- Date of Event
- June 13, 2011
- Report Date
- June 14, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- BTR
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN COMPLETION OF INVESTIGATION.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: COMPLAINT ALLEGES THAT THE 15MM ADAPTER POPPED OFF THE TUBE AND HAD TO BE RECONNECTED. ALLEGED INCIDENT OCCURRED DURING INTUBATION OF A PT. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON HVT ISIS ENDOTRACHEAL CUFF TUBE | ENDOTRACHEAL TUBE | BTR | TELEFLEX MEDICAL | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |