FDA Adverse Event
Malfunction
Summary report: N
MAXPLUS CLEAR NEEDLELESS CONNECTOR
MDR report key: 2251425
·
Received August 10, 2011
Report
- Report Number
- 9616066-2011-00458
- Event Type
- Malfunction
- Date Received
- August 10, 2011
- Report Date
- July 22, 2011
- Manufacturer
- CAREFUSION CORP
- Product Code
- FPA
- PMA / PMN Number
- K072542
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A F/U REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
CUSTOMER REPORTED LEAKING DUE TO THE MEDLINE SYRINGE SPINNING OFF THE MAXPLUS. IT ONLY HAPPENS WITH THE 12 ML PREFILLED SALINE MEDLINE SYRINGE. THERE WAS NO PT HARM AND NO MEDICAL INTERVENTION WAS REQUIRED. ALTHOUGH REQUESTED, NO ADD'L EVENT OR PT INFO PROVIDED BY THE USER.
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 | 12 ML PREFILLED SALINE MEDLINE SYRINGE, LOT# UNK |