FDA Adverse Event
Malfunction
Summary report: N
PORTEX SUCTIONPRO 72 CLOSED SUCTION SYSTEM
MDR report key: 2669663
·
Received July 13, 2012
Report
- Report Number
- 2183502-2012-00301
- Event Type
- Malfunction
- Date Received
- July 13, 2012
- Manufacturer
- SMITHS MEDICAL MD, INC.
- Product Code
- OFR
- PMA / PMN Number
- EXEMPT
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAIL AND IS RETURNED AND EVALUATED THE MFR WILL FILE A FOLLOW UP REPORT DETAILING THE RESULTS OF THE EVAL.
Description of Event or Problem · 1
.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PORTEX SUCTIONPRO 72 CLOSED SUCTION SYSTEM | BSY- TRACHEOBRONCHIAL SUCTION CATHETER | OFR | SMITHS MEDICAL MD, INC. | NA | 2153772 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |