FDA Adverse Event
Malfunction
Summary report: N
ONGUARD CSTD BAG ADAPTOR SPIKE
MDR report key: 23838962
·
Received December 18, 2025
Report
- Report Number
- MW5180804
- Event Type
- Malfunction
- Date Received
- December 18, 2025
- Date of Event
- December 11, 2025
- Report Date
- December 11, 2025
- Manufacturer
- SIMPLIVIA HEALTHCARE LTD.
- Product Code
- ONB
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
SIMPLIVIA ONGUARD 2 CSTD BAG ADAPTOR SP PRODUCT. THE ONGUARD BAG ADAPTOR SPIKE FELL OUT OF AN INFUSION BAG DURING AN INFUSION CAUSING THE CONTENTS OF THE BAG TO SPILL OUT ONTO NURSE AND SURROUNDING AREA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2244357 | ONGUARD CSTD BAG ADAPTOR SPIKE | CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM | ONB | SIMPLIVIA HEALTHCARE LTD. | 412143 | UBE654 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |