FDA Adverse Event
Malfunction
Summary report: N
PORTEX BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE
MDR report key: 3171867
·
Received May 24, 2013
Report
- Report Number
- 2183502-2013-00256
- Event Type
- Malfunction
- Date Received
- May 24, 2013
- Report Date
- May 23, 2013
- Manufacturer
- SMITH MEDICAL INTERNATIONAL LTD.
- Product Code
- JOH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ONE USED SAMPLE WAS RECEIVED FOR EVALUATION. UPON PRESSURIZATION, THE CUFF WAS FOUND TO HOLD PRESSURE AND OPERATE AS INTENDED WITHIN SPECIFICATION; NO LEAKING WAS OBSERVED. THERE WAS NO EVIDENCE FOUND TO SUGGEST THE EVENT WAS CAUSED FROM AN INTRINSIC DEFECT I THE PRODUCT.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT ALLEGES THAT THE TRACHEOSTOMY TUBE WAS DEFLATING AT THE CUFF AFTER 7 DAYS IN SITU. REPLACEMENT WAS REQUIRED. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 230768 | PORTEX BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE | TRACHEOSTOMY TUBES | JOH | SMITH MEDICAL INTERNATIONAL LTD. | NA | 2384066 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |