FDA Adverse Event
Malfunction
Summary report: N
CADD MEDICATION CASSETTE RESERVOIR
MDR report key: 24748955
·
Received March 31, 2026
Report
- Report Number
- 3012307300-2026-03119
- Event Type
- Malfunction
- Date Received
- March 31, 2026
- Date of Event
- March 9, 2026
- Report Date
- April 1, 2026
- Manufacturer
- ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.
- Product Code
- FPA
- UDI-DI
- 10610586027239
- PMA / PMN Number
- K040636
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 0
CASSETTES WITH PARTICLES. TWO LOTS WERE USED FOR THIS PRODUCTION 6171577 ((B)(4)) AND 6147681 ((B)(4)) AND NEITHER LOT HAD BEEN PREVIOUSLY ASSOCIATED WITH A FILED COMPLAINT. THE CASSETTES, USED BY INTEGRADOSE FOR DELIVERY OF HYDROMORPHONE HCL, COULD NOT BE PROVIDED FOR FURTHER EVALUATION, AND PHOTOS OF THE OBSERVED PARTICLES WERE INSTEAD SUPPLIED. STAFF DESCRIBED THE PARTICLES AS ONE SLIVER-SHAPED, ONE ROUND, AND ONE VERY SMALL PARTICLE, CONSISTENT WITH PARTICLE TYPES PREVIOUSLY OBSERVED AT INTEGRADOSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 802752 | CADD MEDICATION CASSETTE RESERVOIR | SET, ADMINISTRATION, INTRAVASCULAR | FPA | ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. | 10610586027239 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |