CARDINAL HEALTH
Report
- Report Number
- 3005670221-2024-00014
- Event Type
- Malfunction
- Date Received
- April 12, 2024
- Report Date
- April 12, 2024
- Manufacturer
- JIANGSU CAINA MEDICAL CO., LTD.
- Product Code
- FMF
- UDI-DI
- 10192253034677
- PMA / PMN Number
- K113091
- Removal / Correction Number
- Z-0855-2024
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE RETURNED SAMPLE IS UNAVAILABLE FOR EVALUATION. THE DHR OF THIS LOT WAS REVIEWED WITHOUT ANY ISSUE. THE DESIGN HISTORY FILE AND 510K SUBMISSION WERE REVIEWED. THIS SYRINGE IS DESIGNED FOR MANUAL USE ONLY, NOT FOR PUMP USE. FOR MANUAL USE OR NOT FOR PUMP USE WAS NOT PRESENTED ON ANY LABELING OF THIS PRODUCT. THE COMPLIANT HISTORY WAS REVIEWED FOUR PUMP COMPATABILITY ISSUES WITH THIS PRODUCT WERE RECEIVED BEFORE. A RECALL WAS CONDUCTED BY DISTRIBUTOR CARDINAL HEALTH 200 LLC WITH RECALL NUMBER Z-0855-2024. THE CORRECTIVE ACTION PUTTING THE CAUTION "FOR MANUAL USE OR NOT FOR PUMP USE" ON ALL SYRINGES' LABELING OF K113091 WILL BE TAKEN. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION FROM THE RECEIVED SAMPLES.
IT WAS REPORTED ANONYMOUSLY BY HEALTH SCIENCE UNIV THAT THE CARDINAL HEALTH MONOJECT 20ML REF: 118200777 SYRINGE IS "SLIGHTLY DIFFERENT" COMPARED TO THE COVIDIEN MONOJECT 20ML SYRINGE REF: 118200777. IT WAS NOTED THAT THE CARDINAL HEALTH MONOJECT 20ML SYRINGE CANNOT BE DETECTED BY THE SYRINGE PUMP. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1470954 | CARDINAL HEALTH | SYRINGE | FMF | JIANGSU CAINA MEDICAL CO., LTD. | 230202 | 10192253034677 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |