FDA Adverse Event
Malfunction
Summary report: N
ALARIS 17 INCH EXT SET W/.2MF & VLV PORT
MDR report key: 9694944
·
Received February 11, 2020
Report
- Report Number
- 9616066-2020-00432
- Event Type
- Malfunction
- Date Received
- February 11, 2020
- Date of Event
- February 6, 2019
- Report Date
- April 15, 2019
- Manufacturer
- CAREFUSION
- Product Code
- FPA
- PMA / PMN Number
- K960280
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
20350E-0006/NO 510K -THIS IS AN INTERNATIONAL CODE- THE MODEL#/CATALOG# IDENTIFIED IS A CAREFUSION PRODUCT WHICH IS SAME OR SIMILAR TO A DEVICE THAT IS APPROVED FOR SALE DOMESTICALLY. THE DOMESTIC SIMILAR LIST NUMBER IS 20350E. THE 510K NUMBER PROVIDED IS FOR THE DOMESTIC SIMILAR PRODUCT-K960280. ALTHOUGH REQUESTED, PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE PRODUCT BE RECEIVED FOR EVALUATION.
Description of Event or Problem · 1
THE REPORTED FEEDBACK SUGGESTS THAT THERE IS A LEAKAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 154581 | ALARIS 17 INCH EXT SET W/.2MF & VLV PORT | SET, EXTENSION, INTRAVASCULAR | FPA | CAREFUSION | 20350E-0006 | 17025908 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |