FDA Adverse Event
Malfunction
Summary report: N
ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT
MDR report key: 3963639
·
Received February 26, 2014
Report
- Report Number
- 9611710-2014-00046
- Event Type
- Malfunction
- Date Received
- February 26, 2014
- Date of Event
- February 4, 2014
- Report Date
- February 4, 2014
- Manufacturer
- UNOMEDICAL SDN BHD
- Product Code
- BTR
- PMA / PMN Number
- K951696
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
BASED ON THE INFORMATION PROVIDED THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. IT WAS REPORTED THAT THE PRODUCT HAD NOT BEEN USED AS THE CUSTOMER FOUND THIS DEFECT DURING THEIR COMING INSPECTION. NO ADDITIONAL EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD A RETURN SAMPLE OR ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. NOTE: THE ACTUAL DATE OF EVENT IS UNKNOWN, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.
Description of Event or Problem · 1
COMPLAINANT REPORTED CONTAMINATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 119155 | ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT | TUBE, TRACHEAL (W/WO CONNECTOR) 73BTR | BTR | UNOMEDICAL SDN BHD | 61110085 | 614857R001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |