FDA Adverse Event
Malfunction
Summary report: N
LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SETS
MDR report key: 2842389
·
Received October 22, 2012
Report
- Report Number
- 2183502-2012-00492
- Event Type
- Malfunction
- Date Received
- October 22, 2012
- Report Date
- October 18, 2012
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- KZL
- PMA / PMN Number
- BK860023
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT YET RECEIVED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.
Description of Event or Problem · 1
THERE WAS A REPORT OF AN OCCURRENCE OF THE FLUID WARMING INFUSION SET TUBING BECOMING KINKED. NO PATIENT 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 | 2100021 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |