FDA Adverse Event
Malfunction
Summary report: N
CE INFUSOR LV 5, 12 PACK
MDR report key: 1884269
·
Received October 27, 2010
Report
- Report Number
- 6000001-2010-04550
- Event Type
- Malfunction
- Date Received
- October 27, 2010
- Date of Event
- October 5, 2010
- Report Date
- October 6, 2010
- Manufacturer
- BAXTER HEALTHCARE - IRVINE
- Product Code
- MEB
- PMA / PMN Number
- K041738
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DEVICE EVALUATION: THE REPORTED CONDITION AS NOT CONFIRMED. THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED AT THIS TIME. ADDITIONAL: A BAXTER REVIEW HAS BEEN PERFORMED AND THERE WERE NO NONCONFORMANCES NOTED DURING THE MANUFACTURING OF THIS PRODUCT.
Additional Manufacturer Narrative · 1
(B)(4). A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT AN INFUSOR THAT HAD A LEAK FROM THE WINGED LUER CAP WHEN TAPPED. THE EVENT OCCURRED BEFORE PATIENT USE. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CE INFUSOR LV 5, 12 PACK | PUMP, INFUSION, ELASTOMERIC | MEB | BAXTER HEALTHCARE - IRVINE | 10F059 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |