UNKNOWN NEEDLES AND SYRINGES
Report
- Report Number
- 1017768-2024-00029
- Event Type
- Malfunction
- Date Received
- March 14, 2024
- Report Date
- September 11, 2025
- Manufacturer
- CARDINAL HEALTH
- Product Code
- FMI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
SAMPLES WERE NOT RECEIVED FOR THE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A LOT NUMBER WAS NOT RECEIVED WITH THE COMPLAINT. BECAUSE A SAMPLE WAS NOT RETURNED, WE WERE UNABLE TO PERFORM A FOLLOW UP INVESTIGATION TO INCLUDE FUNCTIONAL AND VISUAL EVALUATIONS TO CONFIRM THE REPORTED ISSUE AND DETERMINE THE ROOT CAUSE, THEREFORE A CORRECTIVE ACTION IS NOT APPLICABLE AT THIS TIME. IF A SAMPLE IS RECEIVED AT A LATER DATE, THIS COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.
ADDITIONAL EVENT INFORMATION WAS RECEIVED FROM THE CUSTOMER ON 09JUN2024 THEREFORE SECTION B5 WAS UPDATED.
THE DEVICE HISTORY RECORDS FOR THE TWO POSSIBLE LOTS WERE REVIEWED AND INDICATED THAT THE PRODUCTS WERE RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. THERE WERE NO SAFETY NEEDLES OR PHOTOS PROVIDED FOR ANALYSIS. BASED ON THE AVAILABLE INFORMATION, THE REPORTED ISSUE COULD NOT BE OBSERVED, AND AN EXACT ROOT CAUSE WAS NOT DETERMINED. ¿ALL INFORMATION RECEIVED WILL BE USED FOR FURTHER TRACKING AND TRENDING PURPOSES AND WE WILL CONTINUE TO MONITOR.
THE DEVICE HISTORY RECORD (DHR) FOR LOTS 008327 OR 112744 WERE REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE OBSERVED.PRIOR TO A LOT¿S RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY-PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. DURING PRODUCTION, INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. ONE DEVICE WAS RETURNED FOR EVALUATION AND THE REPORTED ISSUE WAS OBSERVED. HOWEVER, THE¿INVESTIGATION DID NOT IDENTIFY A SYSTEMIC ISSUE WITH THE PRODUCT OR PROCESS. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED BASED ON AVAILABLE INFORMATION. THEREFORE, A CORRECTIVE AND PREVENTIVE ACTION (CAPA) IS NOT NECESSARY AT THIS TIME. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.
THE CUSTOMER REPORTED AN ISSUE REGARDING THE USE OF THE SAFETY NEEDLE AND STATED "AMPULE BAGS/PFS/VIAL LEAKS". THE PRODUCT INFORMATION WAS NOT PROVIDED.
THE CUSTOMER REPORTED AN ISSUE REGARDING THE USE OF THE SAFETY NEEDLE AND STATED "AMPULE BAGS/PFS/VIAL LEAKS". ON 09JUN2024 THE CUSTOMER PROVIDED ADDITIONAL INFORMATION STATING THAT THE NURSE COULD NOT COMPLETE THE INJECTION BECAUSE SUSPENSION WAS LEAKING BETWEEN THE NEEDLE AND SYRINGE. POSSIBLE ITEM CODE 8881850215, 8881850310. POSSIBLE LOT NUMBER 008327, 112744.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1320794 | UNKNOWN NEEDLES AND SYRINGES | NEEDLE, HYPODERMIC, SINGLE LUMEN | FMI | CARDINAL HEALTH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |