FDA Adverse Event
Malfunction
Summary report: N
MAXPLUS CLEAR NEEDLELESS CONNECTOR
MDR report key: 2082579
·
Received April 27, 2011
Report
- Report Number
- 3005748548-2011-00008
- Event Type
- Malfunction
- Date Received
- April 27, 2011
- Date of Event
- January 20, 2011
- Report Date
- February 8, 2011
- Manufacturer
- CAREFUSION CORPORATION
- Product Code
- FPA
- PMA / PMN Number
- K072542
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE SET HAS BEEN RECEIVED. THE FAILURE INVESTIGATION IS NOT YET COMPLETE. A F/U REPORT WILL BE SUBMITTED WITH ANY RELEVANT INFO.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT CHEMO LEAKED FROM CONNECTOR DURING INFUSION. NO HARM TO PT OR CLINICIAN REPORTED. NO ADD'L INFO 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 |