FDA Adverse Event
Injury
Summary report: N
PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KITS WITH SINGLE STAGE DILATOR
MDR report key: 2122938
·
Received June 9, 2011
Report
- Report Number
- 2183502-2011-00469
- Event Type
- Injury
- Date Received
- June 9, 2011
- Report Date
- June 7, 2011
- Manufacturer
- SMITHS MEDICAL INTL., LTD.
- Product Code
- BTO
- PMA / PMN Number
- K083031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL.
Description of Event or Problem · 1
USER FACILITY REPORTED THAT THE TRACHEOSTOMY TUBE FROM THE KIT LISTED WAS PLACED IN PT. ACCORDING TO REPORT, THE LOCKING MECHANISM OF THE ADJUSTABLE FLANGE BECAME UNLOCKED INADVERTENTLY DURING MANIPULATION. THE TRACH TUBE SLIPPED BACK THROUGH THE FLANGE WHICH LED TO INTERMITTENT DISTAL TRACHEAL OBSTRUCTION AND CYANOSIS. THE DEVICE WAS REMOVED AND REPLACED. NO FURTHER ADVERSE EFFECTS OR INTERVENTION TO PT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KITS WITH SINGLE STAGE DILATOR | BTO - TRACHEOSTOMY TUBE | BTO | SMITHS MEDICAL INTL., LTD. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |