FDA Adverse Event
Malfunction
Summary report: N
IVT DISPOSABLE
MDR report key: 3230501
·
Received July 16, 2013
Report
- Report Number
- 1416980-2013-18710
- Event Type
- Malfunction
- Date Received
- July 16, 2013
- Date of Event
- June 21, 2013
- Report Date
- June 21, 2013
- Manufacturer
- BAXTER HEALTHCARE - THETFORD
- Product Code
- LHI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NO
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE SAMPLE WAS RECEIVED FOR EVALUATION. THE SAMPLE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. DURING EVALUATION THE DEVICE UNDERWENT A SUBOPTIMAL ACTIVATION TECHNIQUE. THIS TECHNIQUE RESULTED IN A SINGLE GREY PARTICLE, APPROXIMATELY 2 MM IN DIAMETER. THE REPORTED MALFUNCTION WAS DUE TO THE METHOD OF THE USER.
Description of Event or Problem · 1
IT WAS REPORTED THAT LOOSE PARTICLES WERE OBSERVED IN A VIAL-MATE 100ML NACL 9MG/ML AFTER RECONSTITUTION WITH AN UNREPORTED MEDICATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 329169 | IVT DISPOSABLE | SET, I.V. FLUID TRANSFER | LHI | BAXTER HEALTHCARE - THETFORD | 13A30VM01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |