FDA Adverse Event
Malfunction
Summary report: N
VESCO LUER LOCK SYRINGE 20ML
MDR report key: 21936615
·
Received April 30, 2025
Report
- Report Number
- MW5169677
- Event Type
- Malfunction
- Date Received
- April 30, 2025
- Date of Event
- January 21, 2025
- Report Date
- April 24, 2025
- Manufacturer
- JIANGSU CAINA MEDICAL CO., LTD
- Product Code
- FMF
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- *
Narratives
Description of Event or Problem · 0
WE RECEIVED A CASE OF VESCO 20ML LUER LOCK SYRINGES FROM HEALTH CARE LOGISTICS. CUSTOMER STATED, "TWO TIMES TODAY WE HAVE USED THE SYRINGES, AND THE PLASTIC CRACKED LETTING THE IRON FLUID INSIDE TO SPRAY ACROSS THE TECHNICIAN USING IT. THE LOT NUMBER #220101. NOT ALL ARE HAVING THIS DEFECT, BUT IT IS A CONCERN AS WE ARE A CANCER CENTER AND IF CERTAIN CHEMOTHERAPY MEDICATIONS WERE USED TO DO THIS INSTEAD OF THE IRON IT COULD BE A SEVERE HEALTH HAZARD. VESCO NOW HAS THE DEFECTED SYRINGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 191907 | VESCO LUER LOCK SYRINGE 20ML | SYRINGE, PISTON | FMF | JIANGSU CAINA MEDICAL CO., LTD | VIV-620E0 | 220101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |