CARDINAL HEALTH
Report
- Report Number
- 3005670221-2024-00009
- Event Type
- Malfunction
- Date Received
- April 11, 2024
- Report Date
- April 12, 2024
- Manufacturer
- JIANGSU CAINA MEDICAL CO., LTD.
- Product Code
- FMF
- UDI-DI
- 10192253034530
- PMA / PMN Number
- K113091
- Removal / Correction Number
- Z-0851-2024
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
RETURNED SAMPLE WAS REQUESTED BUT HAVEN'T RECEIVED YET. THE DHR OF THIS LOT WAS REVIEWED WITHOUT ANY ISSUE. THE DESIGN HISTORY FILE AND 510K SUMBSSION 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 ONE PUMP COMPATBILITY ISSUE WITH THIS PRODUCT WAS RECEIVED BEFORE. A RECALL WAS CONDUCTED BY DISTRIBUTOR CARDINAL HEALTH 200 LLC WITH RECALL NUMBER Z-0851-2024. THE CORRETIVE 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.
GRADUATED LINES ARE NOT EASILY RECOGNIZED (NEW PLUNGER STRUCTURE) LOTS OF AIR BUBBLES PUMP COMPATIBILITY ISSUES, NOT RECOGNIZED BY INFUSION PUMPS
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 836971 | CARDINAL HEALTH | SYRINGE | FMF | JIANGSU CAINA MEDICAL CO., LTD. | 230201 | 10192253034530 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |