FDA Adverse Event
Malfunction
Summary report: N
MAXPLUS NEEDLELESS CONNECTOR
MDR report key: 2935585
·
Received January 2, 2013
Report
- Report Number
- 9616066-2012-00942
- Event Type
- Malfunction
- Date Received
- January 2, 2013
- Date of Event
- December 19, 2012
- Report Date
- December 20, 2012
- Manufacturer
- CAREFUSION CORP
- Product Code
- FPA
- PMA / PMN Number
- K072542
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A F/U REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVAL.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SILICONE GLAND INITIALLY STICKS THEN POPS AND THEN SQUIRTS BLOOD ON THE NURSE. THE CUSTOMER ACCESSES THE VALVE WITH A BD LUER LOCKING VACUTAINER OR A SYRINGE (TYPE NOT PROVIDED). THERE WAS NO PT HARM REPORTED AND NO MEDICAL INTERVENTION WAS REQUIRED. CUSTOMER STATED THAT NO ADDITIONAL PT OR EVENT DETAILS ARE AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1448 | MAXPLUS NEEDLELESS CONNECTOR | FPA | CAREFUSION CORP | MP1000-C | 12078058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | BD LUER LOCKING VACUTAINER, MODEL/LOT # UNK| SYRINGE, MODEL/LOT # UNK |