FDA Adverse Event
Malfunction
Summary report: N
MAXPLUS CLEAR NEEDLELESS CONNECTOR
MDR report key: 2456374
·
Received February 8, 2012
Report
- Report Number
- 9616066-2012-00094
- Event Type
- Malfunction
- Date Received
- February 8, 2012
- Date of Event
- January 24, 2012
- Report Date
- January 24, 2012
- Manufacturer
- CAREFUSION CORP.
- Product Code
- FPA
- PMA / PMN Number
- K072542
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER STATED THE SET HAS BEEN DISCARDED AND IS NOT AVAILABLE FOR FAILURE INVESTIGATION.
Description of Event or Problem · 1
REPORT RECEIVED FROM CLINICAL PRACTICE CONSULTANT THAT "WHEN A HOSPIRA 1.2 MICRON FILTER EXTENSION SET (#11415-05) IS ATTACHED TO A MAXPLUS CLEAR VALVE (WITH EXTENSION SET), LEAKING OCCURS. WHEN THE MAXPLUS CLEAR IS TAKEN OFF, AND THE FILTER IS ATTACHED DIRECTLY TO THE MAXIMUS EXTENSION SET, NO LEAKING OCCURS." THE USERS INDICATED THIS OCCURS WITH REMICADE INFUSIONS (THE ONLY DRUG GIVEN AT THE INFUSION CENTER USING THE 1.2 MICRON FILTER EXTENSION SET). THERE WAS NO PT HARM REPORTED AND NO MEDICAL INTERVENTION WAS REQUIRED. NO ADDITIONAL PT OR EVENT DETAILS WERE PROVIDED BY THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAXPLUS CLEAR NEEDLELESS CONNECTOR | FPA | CAREFUSION CORP. | MP1000-C | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |