FDA Adverse Event
Malfunction
Summary report: N
LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SETS
MDR report key: 2481978
·
Received February 21, 2012
Report
- Report Number
- 2183502-2012-00039
- Event Type
- Malfunction
- Date Received
- February 21, 2012
- Date of Event
- January 23, 2012
- Report Date
- February 17, 2012
- Manufacturer
- SMITHS MEDICAL ASD, INC
- Product Code
- KZL
- PMA / PMN Number
- BK860023
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVAL SUMMARY: CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MFR WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL.
Description of Event or Problem · 1
THERE WAS A REPORT OF AN OCCURRENCE OF A LEAK OF A FLUID WARMING INFUSION SET. NO PT INJURY OR ADVERSE EVENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SETS | KZL - DISPOSABLE IV FLUID WARMING SET | KZL | SMITHS MEDICAL ASD, INC | NA | 1834727 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |