FDA Adverse Event
Malfunction
Summary report: N
BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC
MDR report key: 14429971
·
Received May 18, 2022
Report
- Report Number
- 3012307300-2022-09007
- Event Type
- Malfunction
- Date Received
- May 18, 2022
- Report Date
- May 11, 2023
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- JOH
- UDI-DI
- 15021312005806
- PMA / PMN Number
- K944178
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE WAS UNABLE TO BE EVALUATED AS IT WAS NOT RETURNED. IF THE DEVICE IS RECEIVED IN THE FUTURE AN EVALUATION WILL BE PERFORMED. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED OR REPLICATED. A CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED AT THIS TIME.
Additional Manufacturer Narrative · 0
OTHER, OTHER TEXT: THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4). PLEASE DISREGARD THE INITIAL REPORT SUBMITTED WITH THE MFR NUMBER: 3012307300-2022-09007. THE REPORT WAS SUBMITTED IN ERROR. DUPLICATE OF 3012307300-2022-09309 (CC-0151286).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE BROKE DURING USE. NO OTHER INFORMATION WAS PROVIDED. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1711043 | BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC | TUBE, TRACHEOSTOMY (W/WO CONNECTOR) | JOH | SMITHS MEDICAL ASD, INC. | 60PFP40 | 15021312005806 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |