FDA Adverse Event
Other
Summary report: N
MALLINCKRODT TAPERGUARD EVAC ORAL TRACHEAL TUBE #7.
MDR report key: 2396894
·
Received December 27, 2011
Report
- Report Number
- 2396894
- Event Type
- Other
- Date Received
- December 27, 2011
- Date of Event
- December 21, 2011
- Report Date
- December 23, 2011
- Manufacturer
- COVIDIEN
- Product Code
- BTR
- Report Source
- User Facility report
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PT'S O2 SAT DROPPING FOR UNK REASON TO 79%. ANESTHESIA UNABLE TO INCREASE SAT, DESPITE MANUAL RESPIRATIONS. SURGEONS PRESENT. SURGEON WAS ABLE TO VISUALIZE OBSTRUCTION INSIDE ENDOTRACHEAL TUBE WITH BRONCHOSPY. ET TUBE D/C'D FOR NEW ET TUBE. OLD ET TUBE FOUND TO HAVE CRACKED, SHREDDING INTERNAL LINING. ET TUBE BAGGED AND LABELED WITH PT STICKER AND GIVEN TO SURGEON. PT'S SAT UP TO 91 - 93%. COVIDIEN MALLINCKRODT TAPERGUARD EVAC ORAL TRACHEAL TUBE #7.5. LOT # IS EITHER 110500068X OR #110601979, BUT MORE LIKELY TO BE FROM THE FIRST LOT NUMBER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MALLINCKRODT TAPERGUARD EVAC ORAL TRACHEAL TUBE #7. | TUBING | BTR | COVIDIEN | 110500068X/110601979 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |