FDA Adverse Event
Malfunction
Summary report: N
SHILEY
MDR report key: 4140814
·
Received October 3, 2014
Report
- Report Number
- 2936999-2014-00873
- Event Type
- Malfunction
- Date Received
- October 3, 2014
- Date of Event
- September 2, 2014
- Report Date
- September 5, 2014
- Manufacturer
- COVIDIEN
- Product Code
- BTO
- PMA / PMN Number
- K090352
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
COVIDIEN REFERENCE: (B)(4). ONE SAMPLE OF AN ENDOTRACHEAL TUBE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED, AND IT WAS OBSERVED THAT THE CUFF EXHIBITED A CUT. INFLATION AND DEFLATION TESTS WERE PERFORM. AIR WAS APPLIED TO THE CUFF AND IT IMMEDIATELY DEFLATED. THE CUSTOMER REPORTED MALFUNCTION WAS VERIFIED. CUTS OF THIS MAGNITUDE WOULD HAVE BEEN DETECTED DURING THE INFLATE DEFLATE TESTS AND REMOVED FROM THE LOT. THE CUT CONDITION FOUND ON THE RETURNED CUFF IS NOT CONFIRMED AS RELATED TO THE MANUFACTURING PROCESS.
Description of Event or Problem · 1
A REPORT WAS RECEIVED STATING THAT A TRACHEAL TUBE EXPERIENCED A LEAK PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 620217 | SHILEY | TRACHEOSTOMY TUBE | BTO | COVIDIEN | 18780 | 14C0317JZX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |