FDA Adverse Event
Malfunction
Summary report: N
AQUASTAT SFR STERILE FIELD READY FLUSH SYRINGE
MDR report key: 9219278
·
Received October 21, 2019
Report
- Report Number
- MW5090532
- Event Type
- Malfunction
- Date Received
- October 21, 2019
- Date of Event
- October 17, 2019
- Report Date
- October 18, 2019
- Manufacturer
- AQUABILITI
- Product Code
- NGT
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
SALINE FLUSH SYRINGE END SHEARED OFF AS IT WAS BEING SCREWED ON TO THE LUER LOCK CAP OF A PICC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1006938 | AQUASTAT SFR STERILE FIELD READY FLUSH SYRINGE | SALINE, VASCULAR ACCESS FLUSH | NGT | AQUABILITI | KH04631 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 93 YR |