FDA Adverse Event
Malfunction
Summary report: N
MAXZERO NEEDLELESS CONNECTOR
MDR report key: 3983733
·
Received June 25, 2014
Report
- Report Number
- 9616066-2014-00609
- Event Type
- Malfunction
- Date Received
- June 25, 2014
- Report Date
- May 30, 2014
- Manufacturer
- CAREFUSION CORPORATION
- Product Code
- FPA
- PMA / PMN Number
- K132413
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.
Description of Event or Problem · 1
CUSTOMER REPORTED WHILE DRAWING BLOOD IN THE PICU THERE WAS BLOOD LEAKING AT THE MAXZERO FEMALE LUER AND PORTEX SYRINGE MALE LUER CONNECTION. NO PATIENT HARM OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER PATIENT/EVENT INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 370940 | MAXZERO NEEDLELESS CONNECTOR | IV SET CONNECTOR | FPA | CAREFUSION CORPORATION | MZ1000-07 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | PORTEX ARTERIAL BLOOD SYRINGE, MODEL 4041-2,| LOT 2684965 |