CARDINALHEALTH
Report
- Report Number
- 3005670221-2024-00049
- Event Type
- Malfunction
- Date Received
- April 13, 2024
- Report Date
- April 13, 2024
- Manufacturer
- JIANGSU CAINA MEDICAL CO., LTD.
- Product Code
- FMF
- UDI-DI
- 10192253033519
- PMA / PMN Number
- K113091
- Removal / Correction Number
- Z-0853-2024
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
RETURNED SAMPLE WAS RECEIVED. 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 NO PUMP COMPATABILITY ISSUES WITH THIS PRODUCT WERE RECEIVED BEFORE. A RECALL WAS CONDUCTED BY DISTRIBUTOR CARDINAL HEALTH 200 LLC WITH RECALL NUMBER Z-0853-2024. THE CORRECTIVE ACTION PUTTING THE CAUTION "FOR MANUAL USE OR NOT FOR PUMP USE" ON ALL SYRINGES' LABELING OF K113091 WILL BE TAKEN.
THE CUSTOMER REPORTED THEY NOTICED THAT THE SYRINGES HAVE THE SAME REF#, HOWEVER ARE CARDINAL BRANDED PACKAGING. THE PLUNGER ON THE CARDINAL BRAND ARE A LITTLE BIT LARGER AND THIS IS CAUSING THE INFUSION PUMPS TO REFUSE THE SYRINGE UNLESS THEY ARE "APPROVED" FOR USE IN THE INFUSION PUMPS. THE CUSTOMER IS ASKING IF WE HAVE DOCUMENTATION OR INFORMATION THAT THESE SYRINGES ARE APPROVED FOR USE IN THE INFUSION PUMPS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 779121 | CARDINALHEALTH | SYRINGE | FMF | JIANGSU CAINA MEDICAL CO., LTD. | 221201 | 10192253033519 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |