CARDINAL HEALTH
Report
- Report Number
- 3005670221-2024-00012
- Event Type
- Malfunction
- Date Received
- April 12, 2024
- Report Date
- April 12, 2024
- Manufacturer
- JIANGSU CAINA MEDICAL CO., LTD.
- Product Code
- FMF
- PMA / PMN Number
- K113091
- Removal / Correction Number
- Z-0856-2024
- 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-0856-2024. 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.
CUSTOMER REPORTS: THE SYRINGE WITH THE GRAY PLUNGER IS THE "OLD" SYRINGE, THE CLEAR SYRINGE IS WHAT WE ARE NOW RECEIVING WITH THE SAME ITEM CODE. OUR ANESTHESIA DEPARTMENT IS HAVING ISSUES WITH THE MACHINES DUE TO THE DESIGN ON THE END OF THE BARREL OF THE NEW SYRINGE ; THE SYRINGE IS JUMPING OUT OF PLACE. YOU CAN SEE THERE IS DEFINITELY A DESIGN DIFFERENCE. THE TOTAL AMOUNT DEFECTIVE IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 838022 | CARDINAL HEALTH | SYRINGE | FMF | JIANGSU CAINA MEDICAL CO., LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |