FDA Adverse Event
Malfunction
Summary report: N
ONGUARD 2 CSTD LUER LOCK ADAPTOR
MDR report key: 22347308
·
Received June 26, 2025
Report
- Report Number
- MW5172034
- Event Type
- Malfunction
- Date Received
- June 26, 2025
- Date of Event
- June 24, 2025
- Report Date
- June 25, 2025
- Manufacturer
- SIMPLIVIA HEALTHCARE LTD.
- Product Code
- ONB
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
ONGUARD LUER LOCK ADAPTOR BECAME LOOSE LEADING TO A CHEMOTHERAPY SPILL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1238768 | ONGUARD 2 CSTD LUER LOCK ADAPTOR | CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM | ONB | SIMPLIVIA HEALTHCARE LTD. | UBM609 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Male |