FDA Adverse Event
Injury
Summary report: N
MALLINCKRODT
MDR report key: 3093762
·
Received April 30, 2013
Report
- Report Number
- 2936999-2013-00331
- Event Type
- Injury
- Date Received
- April 30, 2013
- Date of Event
- April 1, 2013
- Report Date
- April 3, 2013
- Manufacturer
- COVIDIEN
- Product Code
- BTR
- PMA / PMN Number
- K090352
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
COVIDIEN CTS REFERENCE # (B)(4). THE SAMPLE ASSOCIATED TO THIS REPORT IS EXPECTED TO BE RETURNED FOR ANALYSIS.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A LEAKAGE AT CUFF DISTAL AND PROXIMAL, LEAKAGE APPEARS AFTER INTUBATION. THE CUSTOMER CONFIRMED THAT EXTUBATION AND REINTUBATION OF A REPLACEMENT TUBE WAS REQUIRED. THE CUSTOMER CONFIRMED THE TUBE WAS PRETESTED. CUSTOMER CONFIRMED THAT THE TUBE WAS REPLACED WITHOUT FURTHER INCIDENT TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 186787 | MALLINCKRODT | TAPERGUARD ORAL/ NASAL TRACHEAL TUBE | BTR | COVIDIEN | 120401795X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |