FDA Adverse Event
Other
Summary report: N
ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER
MDR report key: 1981362
·
Received February 3, 2011
Report
- Report Number
- 1119193-2011-00003
- Event Type
- Other
- Date Received
- February 3, 2011
- Report Date
- February 3, 2011
- Manufacturer
- HOLLISTER INCORPORATED
- Product Code
- CBH
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
GENERAL PERFORMANCE TRENDS FOR TUBE SLIPPAGE WERE ANALYZED AND FOUND TO BE WITHIN ACCEPTABLE PARAMETERS.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN A RESPIRATORY THERAPIST WAS CHECKING ON A PT, SHE OBSERVED THAT THE 6.5MM ET TUBE HAD SLIPPED OUT BY 5CM. SHE WAS ABLE TO REINSERT IT THE 5CM WITHOUT DIFFICULTY. THE PT HAD NOT BECOME EXTUBATED AND HAD NO ADVERSE RESPONSE. IT WAS STATED THAT THE STRAP THAT WRAPS AROUND THE ET TUBE HAD LACK OF ADHESIVE, WHICH ALLOWED THE TUBE TO SLIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER | ANCHORFAST ETAD | CBH | HOLLISTER INCORPORATED | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |