SALTER LABS
Report
- Report Number
- 3000219639-2022-00033
- Event Type
- Malfunction
- Date Received
- June 28, 2022
- Date of Event
- June 7, 2022
- Report Date
- June 28, 2022
- Manufacturer
- SALTER LABS
- Product Code
- CBI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
THE BULB FALLING OFF THE TRACHEAL BULB SYRINGE INTERRUPTED THERAPY AND CAUSED PATIENT TO BE RE-INTUBATED. PATIENT INVOLVEMENT AS THE AIR LEAK COULD CAUSE HYPOXIA. BASED ON THE REPORTED INFORMATION, THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAVE BEEN MET.
THE BULB FALLING OFF THE TRACHEAL BULB SYRINGE INTERRUPTED THERAPY AND CAUSED PATIENT TO BE RE-INTUBATED. PATIENT INVOLVEMENT AS THE AIR LEAK COULD CAUSE HYPOXIA. BASED ON THE REPORTED INFORMATION, THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAVE BEEN MET. COMPLAINT HISTORY REVIEWED. NO PREVIOUS COMPLAINTS FOR THE H-PSTDL LINE OF PRODUCTS IN THE PREVIOUS 24 MONTHS. ISSUE IS NOT TRENDING. WITHOUT RM OR PICTURES OF DEFECT, COMPLAINT COULD NOT BE CONFIRMED. WELL LEAD COMPLETED INVESTIGATION ON 8/17/2022. MOST LIKELY ROOT CAUSE OF DEFECT WAS EITHER TOO MUCH FORCE APPLIED TO BOND OR NOT ENOUGH SOLVENT APPLIED TO BOND. PRODUCT IS 100% LEAK TESTED AS PART OF MANUFACTURING PROCESS. RISK(RMA-20024B): R16: DELAY IN THERAPY - MISSING COMPONENTS OR DISCONNECTED PARTS - S=6 O=1 RPN=6. RPN < 25 THEREFORE RISK IS ACCEPTABLE.
BULB FELL OFF THE TRACHEAL BULB SYRINGE.
BULB FELL OFF THE TRACHEAL BULB SYRINGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 703994 | SALTER LABS | ENDO-BRONCH, STANDARD TIP, DOUBLE LUMEN TUBE, LEFT, 39 FR | CBI | SALTER LABS | H-PSTDL-39-1 | 2105DL0979E |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |