FDA Adverse Event
Injury
Summary report: N
REDITUBE¿ TRACHEAL TUBE ORAL/NASAL WITH PRELOADED STYLET
MDR report key: 15978308
·
Received December 14, 2022
Report
- Report Number
- 8030673-2022-00285
- Event Type
- Injury
- Date Received
- December 14, 2022
- Date of Event
- November 14, 2022
- Report Date
- December 14, 2022
- Manufacturer
- WELL LEAD MEDICAL CO. LTD
- Product Code
- BTR
- UDI-DI
- 10190752148758
- PMA / PMN Number
- K042683
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. NO ROOT CAUSE HAS BEEN DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 0
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 8070RTC - ET TUBE W/ STYLET, CUFFED SIZE 7 WOULD NOT HOLD AIR IN BALLOON FOR A SPINE PROCEDURE.A DECISION WAS MADE TO FLIP THE PATIENT SUPINE AND REINTUBATE WITH A NEW ETT (ENDOTRACHEAL TUBE). THE CUFF WAS CHECKED PRIOR TO INTUBATION FOR LOSS OF AIR, AND NONE WAS PRESENT BUT A SMALL HOLE IN THE BALLOON CUFF WAS FOUND.AT THIS TIME, THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION REGARDING PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2864669 | REDITUBE¿ TRACHEAL TUBE ORAL/NASAL WITH PRELOADED STYLET | BASIC ENDOTRACHEAL TUBE, SINGLE-USE | BTR | WELL LEAD MEDICAL CO. LTD | ET TUBE W/ STYLET, CUFFED SIZE 7 | 22A016703K | 10190752148758 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |