FDA Adverse Event
Malfunction
Summary report: N
N/A
MDR report key: 2212295
·
Received August 15, 2011
Report
- Report Number
- 2090040-2011-00016
- Event Type
- Malfunction
- Date Received
- August 15, 2011
- Date of Event
- July 19, 2011
- Report Date
- July 19, 2011
- Product Code
- JOH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
STRYKER SUSTAINABILITY SOLUTIONS (SSS) RESTERILIZED THE COMPLAINT DEVICE THROUGH OUR OPEN-BUT-UNUSED PROCESS. AN INVESTIGATION DETERMINED THE DEVICE LENGTH WAS 55MM HOWEVER THE SSS LABEL INDICATED IT WAS 45MM IN LENGTH. THIS COULD HAVE BEEN DUE TO AN ERROR WHEN IMPUTING THE DEVICE INFORMATION INTO SSS'S DATABASE OR IT COULD HAVE BEEN SENT TO SSS WITH THE INCORRECT INFORMATION ON THE OEM LABEL. THE LABELING DISCREPANCY WAS FOUND WHILE THE DEVICE WAS IN INVENTORY.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE IN INVENTORY, IT WAS NOTICED THAT A TRACHEOSTOMY TUBE APPEARED TO BE A DIFFERENT LENGTH THAN WHAT WAS REPORTED ON THE LABEL. THE DEVICE WAS NEVER USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | N/A | JOH | JOH | 355-5.5 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |