FDA Adverse Event
Malfunction
Summary report: N
ROBERTAZZI NASAL AIRWAY
MDR report key: 851727
·
Received May 17, 2007
Report
- Report Number
- 8040412-2007-00004
- Event Type
- Malfunction
- Date Received
- May 17, 2007
- Date of Event
- March 26, 2007
- Report Date
- March 26, 2007
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- BTQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN REQUESTED FOR EVAL, BUT THE INSTITUTION DISCARDED THE PROD. DETAILED ROOT CAUSE CANNOT BE DETERMINED DUE TO LACK OF SAMPLE FOR EVAL. NO DHR REVIEW COULD BE DONE DUE TO LACK OF LOT #. MFR WILL CONTINUE TO TRACK AND TREND FOR SIMILAR INCIDENTS.
Description of Event or Problem · 1
CUSTOMER REPORTED, THE PHALANGE ON THE NASAL AIRWAY IS TOO SOFT AND COLLAPSES WHEN ATTEMPTING TO INSERT. NO PT INJURY REPORTED. UPON REVIEW OF THIS FILE, THE DECISION TO FILE A MDR WAS BASED UPON, A PRIOR MDR THAT WAS FILED WITH SAME PROD FAMILY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ROBERTAZZI NASAL AIRWAY | NASAL AIRWAY | BTQ | TELEFLEX MEDICAL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |