FDA Adverse Event
Malfunction
Summary report: N
DIC LARYNGECTOMY; DIC TRACHEOSTOMY TUBE
MDR report key: 15476633
·
Received September 24, 2022
Report
- Report Number
- 3012307300-2022-20202
- Event Type
- Malfunction
- Date Received
- September 24, 2022
- Date of Event
- February 1, 2020
- Report Date
- September 23, 2022
- Manufacturer
- NULL
- Product Code
- BTO
- PMA / PMN Number
- K903730
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
UDI INFORMATION IS UNKNOWN. OPERATOR OF DEVICE IS UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. MANUFACTURING SITE ADDRESS IS UNKNOWN. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED BY THE SUPPLIER. PRODUCT WAS RECEIVED AT SUPPLIER SITE FOR INVESTIGATION. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT VALVE OPENER BECAME MELTED AFTER THE PRODUCT UNDERWENT AUTOCLAVE STERILIZATION AT 135 DEGREES CELSIUS FOR 5 MINUTES. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1527630 | DIC LARYNGECTOMY; DIC TRACHEOSTOMY TUBE | TUBE, TRACHEOSTOMY (W/WO CONNECTOR) | BTO | 0000210785 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |