FDA Adverse Event
Malfunction
Summary report: N
ONGUARD2
MDR report key: 16851333
·
Received May 2, 2023
Report
- Report Number
- 9611423-2023-00002
- Event Type
- Malfunction
- Date Received
- May 2, 2023
- Date of Event
- April 3, 2022
- Report Date
- May 2, 2022
- Manufacturer
- SIMPLIVIA HEALTHCARE LTD
- Product Code
- ONB
- PMA / PMN Number
- K192866
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THERE IS NO RECORD OF THE DEVICE LOT OR UDI, THEREFORE A PROPER INVESTIGATION COULD NOT BE CARRIED OUT.
Description of Event or Problem · 0
RN WAS PREPARING TO HANG CHEMOTHERAPY AND THE ONGUARD (R) 2 CSTD SYRINGE ADAPTOR ON THE END OF THE LINE FAILED, BREAKING OFF AND EXPOSING THE NEEDLE. THIS WAS A DESENSITIZATION, SO THE LINE WAS PRIMED WITH DRUG CREATING A POTENTIAL EXPOSURE RISK. NO CHEMO WAS NOTED TO HAVE SPILLED OR DRIPPED. THE PRODUCT WAS DISCARDED AS A SHARP WHICH CONTAINED CHEMOTHERAPY. PATIENT NOT IMPACTED. STAFF NOT EXPOSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 124074 | ONGUARD2 | SYRINGE ADAPTOR | ONB | SIMPLIVIA HEALTHCARE LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |