FDA Adverse Event
Malfunction
Summary report: N
MAXPLUS CLEAR NEEDLELESS CONNECTOR
MDR report key: 4230950
·
Received October 15, 2014
Report
- Report Number
- 9616066-2014-01057
- Event Type
- Malfunction
- Date Received
- October 15, 2014
- Date of Event
- September 18, 2014
- Report Date
- September 18, 2014
- Manufacturer
- CAREFUSION CORPORATION
- Product Code
- FPA
- PMA / PMN Number
- K072542
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE MODEL#/CATALOG# IDENTIFIED IS A CAREFUSION PRODUCT WHICH IS SAME OR SIMILAR TO A DEVICE THAT IS APPROVED FOR SALE DOMESTICALLY. ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE MAXPLUS VALVE DID NOT CLOSE AFTER DISCONNECTION OF A MORPHINE AND NTP INFUSION. FROM THE REPORTED INFORMATION THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PATIENT OR USER AS A RESULT OF THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 652622 | MAXPLUS CLEAR NEEDLELESS CONNECTOR | ACCESS DEVICE | FPA | CAREFUSION CORPORATION | MP1000C-0006 | 14048081 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |