FDA Adverse Event
Malfunction
Summary report: N
SET, ADMINISTRATION, INTRAVASCULAR
MDR report key: 19711849
·
Received July 10, 2024
Report
- Report Number
- 2523676-2024-00688
- Event Type
- Malfunction
- Date Received
- July 10, 2024
- Date of Event
- June 17, 2024
- Report Date
- July 10, 2024
- Manufacturer
- B. BRAUN MEDICAL INC.
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). NO SAMPLE WAS PROVIDED FOR EVALUATION. BASED ON THE DATA FROM THE INVESTIGATION WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED INCIDENT. THE REPORTED DEFECT WAS UNABLE TO BE CONFIRMED. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.
Description of Event or Problem · 0
AS REPORTED BY THE USER FACILITY: (B)(4). EQUIPMENT ASSET NUMBER: 04-3017. SN# (B)(6). ISSUE: AIR IN LINE ALARM- INAPPROPRIATE. WORK ORDER # FROM NUVOLO: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 351491 | SET, ADMINISTRATION, INTRAVASCULAR | FPA | B. BRAUN MEDICAL INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |