FDA Adverse Event
Malfunction
Summary report: N
BD EXTENSION SET SMALLBORE TUBING FILTER
MDR report key: 17409681
·
Received July 26, 2023
Report
- Report Number
- MW5120212
- Event Type
- Malfunction
- Date Received
- July 26, 2023
- Date of Event
- July 17, 2023
- Report Date
- July 24, 2023
- Manufacturer
- BECTON DICKINSON AND COMPANY
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
LEAKING LIPIDS (IN CENTRAL LINE OF PATIENT) AT FILTER. PRODUCT BECTON DICKINSON AND COMPANY EXTENSION SET SMALLBORE TUBING 1.2 MICRON LOW PROTEIN BINDING FILTER. LOT (10)22019236.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1458105 | BD EXTENSION SET SMALLBORE TUBING FILTER | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BECTON DICKINSON AND COMPANY | 01 10885403234903 | (10)22019236 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 DA | Female |