FDA Adverse Event
Injury
Summary report: N
LUER ACTIVATED VALVE FOR IVACCESS
MDR report key: 1493321
·
Received October 7, 2009
Report
- Report Number
- 6000001-2009-00995
- Event Type
- Injury
- Date Received
- October 7, 2009
- Date of Event
- August 1, 2009
- Report Date
- October 5, 2009
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FPA
- PMA / PMN Number
- K924721
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
INITIALLY THE FACILITY ADVISED SAMPLES WOULD BE RETURNED FOR EVALUATION. AS OF 2009, THE FACILITY ADVISED THE SAMPLES AVAILABLE ARE UNRELATED TO THE BLOOD STREAM INFECTION (BSI) COMPLAINTS. NO SAMPLES ARE AVAILABLE AND THE LOT NUMBER IS UNKNOWN.
Description of Event or Problem · 1
DURING A FOLLOW UP CALL TO THE FACILITY IN 2009, THE COMPLIANCE PERSON REPORTED THAT A 6TH PATIENT EXPERIENCED A BLOODSTREAM INFECTION (BSI) RELATED TO THE CENTRAL VENOUS ACCESS DEVICE DURING USE WITH A CLEARLINK LUER ACTIVATED VALVE, LOT NUMBER UNKNOWN. THE BSI OCCURRED ON AN UNKNOWN DATE IN 2009. IT IS UNKNOWN WHAT INTERVENTIONS WERE REQUIRED. THIS COMPLAINT IS RELATED TO MULTIPLE BSI REPORTS (PATIENTS) FROM THE SAME FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LUER ACTIVATED VALVE FOR IVACCESS | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BAXTER HEALTHCARE - SINGAPORE | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |