17" (43 CM) APPX 5.4 ML, BIFUSE ADD-ON SET W/CHEMOLOCK¿, 3 CLAMPS (BLUE, 2 WHITE
Report
- Report Number
- 9617594-2025-00017
- Event Type
- Malfunction
- Date Received
- January 3, 2025
- Date of Event
- September 1, 2024
- Report Date
- January 3, 2025
- Manufacturer
- ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
- Product Code
- FMG
- UDI-DI
- 00840619082215
- PMA / PMN Number
- K173477
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE DEVICE WAS RECEIVED FOR EVALUATION AND, IT WAS OBSERVED SMALL WHITE PARTICULATE FLOATING IN THE DRIP CHAMBER. NO ASSIGNABLE CAUSE RELATED TO ICU MEDICAL PRODUCT MANUFACTURING OR DESIGN WAS IDENTIFIED. REPORTED CONDITION WAS REPLICATED WHEN USING THE DRIP CHAMBER SPIKE PROVIDED BY THE CUSTOMER AND THE SHAPE OF THIS DRIP CHAMBER USED TO ACCESS THE ICU MEDICAL DRY SPIKE IS CONSIDERED THE MOST RELEVANT FACTOR TO CREATE THESE PARTICULATES. PROBABLE CAUSE, UNKNOWN. THE LOT HISTORY WAS REVIEWED, NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.
THE EVENT INVOLVED A 17" (43 CM) APPX 5.4 ML, BIFUSE ADD-ON SET W/CHEMOLOCK¿, 3 CLAMPS (BLUE, 2 WHITE), DRY SPIKE ADAPTER AND THE CUSTOMER REPORTED A GENERIC COMPLAINT WITH NO SPECIFIC MALFUNCTION. THE DEVICE WAS RETURNED FOR EVALUATION AND IT WAS FOUND THAT THERE WERE PARTICLES IN THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 670108 | 17" (43 CM) APPX 5.4 ML, BIFUSE ADD-ON SET W/CHEMOLOCK¿, 3 CLAMPS (BLUE, 2 WHITE | STOPCOCK, I.V. SET | FMG | ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. | 13979356 | 00840619082215 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |