FDA Adverse Event
Malfunction
Summary report: N
LOCAL ANESTHESIA CUSTOM PACK (EPIDURAL)
MDR report key: 25271638
·
Received May 25, 2026
Report
- Report Number
- 3012307300-2026-05326
- Event Type
- Malfunction
- Date Received
- May 25, 2026
- Date of Event
- April 1, 2026
- Report Date
- May 25, 2026
- Manufacturer
- ICU MEDICAL, INC.
- Product Code
- BZG
- PMA / PMN Number
- UNKNOWN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
B3: (B)(6) 2026 WAS THE REPORTED MONTH/YEAR OF THE EVENT, BUT THE EXACT DAY WAS NOT PROVIDED. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION.
Description of Event or Problem · 0
IT WAS REPORTED THAT THREE INSTANCES OF FLUID LEAKAGE OCCURRED FROM WITHIN THE NRFIT SYRINGE PLUNGER. THE EVENT OCCURRED DURING PATIENT USE AT THE FACILITY. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 504070 | LOCAL ANESTHESIA CUSTOM PACK (EPIDURAL) | EPIDURAL CATHETER KIT | BZG | ICU MEDICAL, INC. | 251223 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |