FDA Adverse Event
Malfunction
Summary report: N
MAXPLUS CLEAR NEEDLELESS CONNECTOR
MDR report key: 2082568
·
Received April 27, 2011
Report
- Report Number
- 3005748548-2011-00005
- Event Type
- Malfunction
- Date Received
- April 27, 2011
- Date of Event
- March 21, 2011
- Report Date
- March 21, 2011
- Manufacturer
- CAREFUSION CORPORATION
- Product Code
- FPA
- PMA / PMN Number
- K072542
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4): DEVICE #1. ALTHOUGH REQUESTED, THE DEVICE HAS NOT BEEN RECEIVED YET. A F/U REPORT WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RECEIVED AND A FAILURE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
RECEIVED REPORT THAT A NURSE IN PICU EXPERIENCED BLOOD SPRAYING BACK AFTER DISCONNECT. NO HARM TO PT. CLINICIAN REPORTED BLOOD SPRAYED FROM PT INTO EYE. CLINICIAN REPORTED EVENT TO OCCUPATIONAL HEALTH. NO ADD'L INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAXPLUS CLEAR NEEDLELESS CONNECTOR | FPA | CAREFUSION CORPORATION | MP1000-C | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |