FDA Adverse Event
Malfunction
Summary report: N
MAXPLUS CLEAR NEEDLELESS CONNECTOR
MDR report key: 2082580
·
Received April 27, 2011
Report
- Report Number
- 3005748548-2011-00006
- 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). ALTHOUGH THE DEVICE HAS BEEN REQUESTED, IT HAS NOT YET BEEN RECEIVED. A F/U REPORT WILL BE SUBMITTED WITH ANY RELEVANT INFO.
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 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 |