FDA Adverse Event
Injury
Summary report: N
MAXPLUS NEEDLELESS CONNECTOR
MDR report key: 3230008
·
Received July 10, 2013
Report
- Report Number
- 9616066-2013-00506
- Event Type
- Injury
- Date Received
- July 10, 2013
- Date of Event
- December 16, 2012
- Report Date
- June 14, 2013
- Manufacturer
- CAREFUSION CORPORATION
- Product Code
- FPA
- PMA / PMN Number
- K072542
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER'S REPORT DATE: (B)(4) 2013. . CUSTOMER STATED THAT NO PRODUCT WILL BE RETURNED, REASON UNKNOWN.
Description of Event or Problem · 1
THE CUSTOMER REPORTED PATIENT WITH A PICC LINE REQUIRED 6 DOSES OF CATHFLO DUE TO CLOTTING OR FIBRIN WITHIN OR AT THE TIP OF THE CATHETER. ALTHOUGH ADDITIONAL DETAILS HAVE BEEN REQUESTED, CUSTOMER STATED THAT NO ADDITIONAL PATIENT OR EVENT DETAILS ARE AVAILABLE AND IT IS UNKNOWN WHAT CAREFUSION PRODUCT PROBLEM IS ALLEGED. CUSTOMER STATED THAT NO ADDITIONAL PATIENT OR EVENT DETAILS ARE AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 317870 | MAXPLUS NEEDLELESS CONNECTOR | FPA | CAREFUSION CORPORATION | MP1000-C | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention | PICC LINE: MANUFACTURER UNK, MODEL #UNK, LOT #UNK |