FDA Adverse Event
Malfunction
Summary report: N
SYRINGE, PISTON
MDR report key: 18523367
·
Received January 17, 2024
Report
- Report Number
- 3005670221-2023-00009
- Event Type
- Malfunction
- Date Received
- January 17, 2024
- Report Date
- September 12, 2023
- Manufacturer
- JIANGSU CAINA MEDICAL CO., LTD.
- Product Code
- FMF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE PRODUCT SHOULD BE MANUAL USE, NOT BE USED IN CONNECTION WITH PUMP. THIS IS UNINTENDED USE ISSUE, NOT A PRODUCT QUALITY ISSUE.
Description of Event or Problem · 0
THE CUSTOMER REPORTED THEY ARE USING THE CAH BRAND SYRINGES IN THE ALARIS INFUSION PUMP AND EXPERIENCING MEDICATION DELIVERING FASTER THAN SHOULD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2003951 | SYRINGE, PISTON | FMF | JIANGSU CAINA MEDICAL CO., LTD. | 20ML |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |