FDA Adverse Event
Malfunction
Summary report: N
MAXGUARD BLOOD COLLECTION TUBE HOLDER
MDR report key: 2082591
·
Received April 27, 2011
Report
- Report Number
- 3005748548-2011-00001
- Event Type
- Malfunction
- Date Received
- April 27, 2011
- Date of Event
- January 1, 2011
- Report Date
- February 17, 2011
- Manufacturer
- CAREFUSION CORPORATION
- Product Code
- FPA
- PMA / PMN Number
- K072542
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DEVICE HAS BEEN RECEIVED BUT THE INVESTIGATION IS NOT COMPLETE. A F/U REPORT WILL BE SUBMITTED WITH ADD'L INFO ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
RECEIVED REPORT THAT SAMPLES WERE TAKEN FROM NEEDLELESS PORT CLOSEST TO PATIENT AT RHEUMATOLOGY CLINIC. LAB REPORTED HEMOLYSIS. NO HEMOLYSIS REPORTED WHEN BLOOD DRAW FROM SMARTSITE INTO A SYRINGE. NO PATIENT OR CLINICAL HARM REPORTED. NO ADD'L INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAXGUARD BLOOD COLLECTION TUBE HOLDER | FPA | CAREFUSION CORPORATION | MBC6000 | 301100418 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | EXPIRATION DATE: 11/01/2013| TREATMENT DATE:| MODEL 10010454, LOT 10116260| ALARIS PUMP MODULE ADMINISTRATION SET |