FDA Adverse Event
Malfunction
Summary report: N
AQUASTAT 10ML/12ML SINGLE DOSE FLUSH SYRINGE
MDR report key: 6180009
·
Received December 16, 2016
Report
- Report Number
- 1000151124-2016-00007
- Event Type
- Malfunction
- Date Received
- December 16, 2016
- Date of Event
- December 4, 2016
- Report Date
- December 15, 2016
- Manufacturer
- AQUABILITI
- Product Code
- NGT
- UDI-DI
- 00859809005026
- PMA / PMN Number
- K111034
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
(B)(4) AFTER COMPLETING THE FLUSH, THE CLINICIAN PROCEEDED TO REMOVE THE SYRINGE FROM THE FISTULA NEEDLE AND THE LUER FROM ONE OF AQUABILITI'S SYRINGES BROKE OFF AND REMAINED IN THE HUB. THE PATIENT'S FISTULA NEEDLE REQUIRED REPLACING. AGREED TO SEND THE REJECTED SYRINGE BACK TO AQUABILITI FOR EVALUATION IF HER CORPORATE OFFICE ADVISED HER TO COMPLY. ATTEMPTS TO REACH HER BY PHONE ON 08-DEC-2016 @ 14:23 AND 09-DEC-2016 @12:53 WERE NOT SUCCESSFUL IN GETTING CONFIRMATION ON THE RETURN OF THE DEFECTIVE SYRINGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 831126 | AQUASTAT 10ML/12ML SINGLE DOSE FLUSH SYRINGE | SALINE, VASCULAR ACCESS FLUSH | NGT | AQUABILITI | 2T0806 | KH04327 | 00859809005026 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |