FDA Adverse Event
Malfunction
Summary report: N
PORTEX RSP TRACHEAL TUBE HOLDERS
MDR report key: 3170420
·
Received May 24, 2013
Report
- Report Number
- 2183502-2013-00254
- Event Type
- Malfunction
- Date Received
- May 24, 2013
- Date of Event
- April 22, 2013
- Report Date
- May 23, 2013
- Manufacturer
- SMITHS MEDICAL INTERNATIONAL LTD
- Product Code
- JAY
- PMA / PMN Number
- K802675
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.
Description of Event or Problem · 1
USER FACILITY REPORTED THAT THE TUBE HOLDER IS SEPARATING FROM THE TAB, WHICH IN TURN IS NOT SECURING THE TUBE CORRECTLY. NO PERMANENT ADVERSE EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 230795 | PORTEX RSP TRACHEAL TUBE HOLDERS | JAY - BREATHING TUBE SUPPORT | JAY | SMITHS MEDICAL INTERNATIONAL LTD | NA | 2329583 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |