CARDINAL HEALTH
Report
- Report Number
- 3005670221-2024-00076
- Event Type
- Malfunction
- Date Received
- April 13, 2024
- Report Date
- April 14, 2024
- Manufacturer
- JIANGSU CAINA MEDICAL CO., LTD.
- Product Code
- FMF
- UDI-DI
- 10192253034691
- PMA / PMN Number
- K113091
- Removal / Correction Number
- Z-0854-2024
- 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 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-0854-2024. 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.
THE CUSTOMER REPORTED AN ERROR MESSAGE INDICATING "OCCLUDED" IS SHOWING ON THE ALARIS PUMP IN THE NICU DEPARTMENT. THE ALARIS PUMPS IN NICU HAVE THE LATEST UPDATE. THE OCCLUSION ALARM INDICATES INCREASED BACK PRESSURE SENSED WHILE INFUSING. THE TUBING HAS NOT CHANGED. THE CUSTOMER STATES THEY FILL THE SYRINGES BEFORE USE SO THEY ARE NOT OCCLUDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 779147 | CARDINAL HEALTH | SYRINGE | FMF | JIANGSU CAINA MEDICAL CO., LTD. | 10192253034691 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |