FDA Adverse Event
Malfunction
Summary report: N
AEROGEN 60ML CONTINUOUS NEBULIZER SYRINGE
MDR report key: 18929058
·
Received March 18, 2024
Report
- Report Number
- MW5152946
- Event Type
- Malfunction
- Date Received
- March 18, 2024
- Report Date
- March 14, 2024
- Manufacturer
- AEROGEN LTD.
- Product Code
- CAF
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
AEROGEN 60ML SYRINGES ARE UTILIZED FOR CONTINUOUS NEBULIZATION OF EPOPROSTENOL. WE HAVE REPORTS FROM OUR PHARMACY AND RT COLLEAGUES THAT THESE SYRINGES ARE LEAKING. IT HAS BEEN NOTED THAT THE SEAL AROUND THE PLUNGER IS COMPROMISED AND THERE IS THE PRESENCE OF FLUID PASSING THE MEMBRANE. IN ADDITION, OUR PHARMACY TECHNICIANS HAVE REPORTED "WEAKENED" PLUNGERS WHEN FILLING THE SYRINGES. THE MANUFACTURER HAS BEEN CONTACTED AND REQUESTED THE IMPACTED PRODUCT TO BE RETURNED. IMPACTED LOT #S IDENTIFIED: HM20110 AND HM21009. REFERENCE REPORT: MW5152947.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 754428 | AEROGEN 60ML CONTINUOUS NEBULIZER SYRINGE | NEBULIZER (DIRECT PATIENT INTERFACE) | CAF | AEROGEN LTD. | HM20110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |