FDA Adverse Event
Malfunction
Summary report: N
BD HALO ONE
MDR report key: 24461699
·
Received February 26, 2026
Report
- Report Number
- MW5184500
- Event Type
- Malfunction
- Date Received
- February 26, 2026
- Date of Event
- November 26, 2025
- Report Date
- February 24, 2026
- Manufacturer
- BD / C. R. BARD, INC. / CLEARSTREAM TECHNOLOGIES LTD.
- Product Code
- DYB
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CO, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PRODUCT NOT USABLE DUE TO NO- FUNCTIONING SECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 513407 | BD HALO ONE | INTRODUCER, CATHETER | DYB | BD / C. R. BARD, INC. / CLEARSTREAM TECHNOLOGIES LTD. | HLO59035 | CMJZ0262 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Male |