BD ALARIS SMARTSITE NEEDLE-FREE VALVE
Report
- Report Number
- 2243072-2025-00875
- Event Type
- Malfunction
- Date Received
- July 15, 2025
- Date of Event
- June 16, 2025
- Report Date
- August 22, 2025
- Manufacturer
- BECTON DICKINSON
- Product Code
- FPA
- PMA / PMN Number
- K960280
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
FIVE 2000E7D SAMPLES FROM LOT 1030534 WERE RECEIVED IN SEALED PACKAGING FOR INVESTIGATION OF (B)(4), IN WHICH THE CUSTOMER HAS STATED: "SMARTSITE DOES NOT PERFORM THE NECESSARY CLOSING PROCEDURES AFTER THE SYRINGE IS INSERTED INTO AND REMOVED FROM THE VEIN VALVE, RESULTING IN ACTIVE BLOOD FLOW FROM THE VEIN." FURTHER CORRESPONDENCE WITH THE CUSTOMER HAS CONFIRMED THAT THE USER DID NOT ACCESS THE SMARTSITE WITH A NEEDLE. EXAMINATION OF THE FIVE UNUSED SAMPLES PROVIDED BY THE CUSTOMER FOUND NO DAMAGE OR DEFECTS WHICH MAY HAVE CONTRIBUTED TO THE CUSTOMER'S EXPERIENCE. FURTHERMORE, NO FLUID LEAKAGE WAS OBSERVED DURING FUNCTIONAL TESTING WITH A BD PLASTIPAK SYRINGE. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION, WHERE A REVIEW OF THE PRODUCTION RECORDS FOR LOT 1030534 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE CAUSED OR CONTRIBUTED TO A REPORT OF THIS NATURE. THE CUSTOMER¿S EXPERIENCE WAS NOT CONFIRMED IN THIS INSTANCE AS TESTING OF THE RETURNED UNUSED SAMPLES AND A REVIEW OF THE PRODUCTION RECORDS DID NOT IDENTIFY ANY PRODUCT DEFECTS OR QUALITY DEVIATIONS DURING ASSEMBLY. THE ALLEGED COMPLAINT SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION THEREFORE IT WAS NOT POSSIBLE TO CONFIRM WHETHER A MANUFACTURING DEFECT MAY HAVE CONTRIBUTED TO THE REPORTED LEAKAGE. IN THIS INSTANCE, WITHOUT THE COMPLAINT SAMPLE OR ADDITIONAL INFORMATION ABOUT THE EXACT NATURE OF THE DEFECT IT IS NOT POSSIBLE TO CONCLUSIVELY LINK THIS FEEDBACK TO A SPECIFIC FAILURE MODE.
FIVE 2000E7D SAMPLES FROM LOT 1030534 WERE RECEIVED IN SEALED PACKAGING FOR INVESTIGATION OF (B)(4), IN WHICH THE CUSTOMER HAS STATED: "SMARTSITE DOES NOT PERFORM THE NECESSARY CLOSING PROCEDURES AFTER THE SYRINGE IS INSERTED INTO AND REMOVED FROM THE VEIN VALVE, RESULTING IN ACTIVE BLOOD FLOW FROM THE VEIN." FURTHER CORRESPONDENCE WITH THE CUSTOMER HAS CONFIRMED THAT THE USER DID NOT ACCESS THE SMARTSITE WITH A NEEDLE. EXAMINATION OF THE FIVE UNUSED SAMPLES PROVIDED BY THE CUSTOMER FOUND NO DAMAGE OR DEFECTS WHICH MAY HAVE CONTRIBUTED TO THE CUSTOMER'S EXPERIENCE. FURTHERMORE, NO FLUID LEAKAGE WAS OBSERVED DURING FUNCTIONAL TESTING WITH A BD PLASTIPAK SYRINGE. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION, WHERE A REVIEW OF THE PRODUCTION RECORDS FOR LOT 1030534 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE CAUSED OR CONTRIBUTED TO A REPORT OF THIS NATURE. THE CUSTOMER¿S EXPERIENCE WAS NOT CONFIRMED IN THIS INSTANCE AS TESTING OF THE RETURNED UNUSED SAMPLES AND A REVIEW OF THE PRODUCTION RECORDS DID NOT IDENTIFY ANY PRODUCT DEFECTS OR QUALITY DEVIATIONS DURING ASSEMBLY. THE ALLEGED COMPLAINT SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION THEREFORE IT WAS NOT POSSIBLE TO CONFIRM WHETHER A MANUFACTURING DEFECT MAY HAVE CONTRIBUTED TO THE REPORTED LEAKAGE. IN THIS INSTANCE, WITHOUT THE COMPLAINT SAMPLE OR ADDITIONAL INFORMATION ABOUT THE EXACT NATURE OF THE DEFECT IT IS NOT POSSIBLE TO CONCLUSIVELY LINK THIS FEEDBACK TO A SPECIFIC FAILURE MODE.
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE NEEDLE-FREE VALVE HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SMARTSITE DOES NOT PERFORM THE NECESSARY CLOSING PROCEDURES AFTER THE SYRINGE IS INSERTED INTO AND REMOVED FROM THE VEIN VALVE, RESULTING IN ACTIVE BLOOD FLOW FROM THE VEIN. ONCE THE CANNULA IS ATTACHED, IT ACTIVELY LEAKS BLOOD. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: WHEN DID THE INCIDENT OCCUR? AFTER USE WAS PATIENT OR USER HARMED? IF YES, PLEASE EXPLAIN. NO, NEITHER THE PATIENT NOR THE USER WAS HARMED. PLEASE CONFIRM IF THE SMARTSITE HAD BEEN ACCESSED WITH A NEEDLE? NO, THE SMARTSITE WAS NOT ACCESSED WITH A NEEDLE PLEASE CONFIRM IF ANY PHYSICAL DAMAGE OR DEFORMITY WAS OBSERVED AT THE POINT OF LEAKAGE? I.E., WAS THE TOP OF THE SMARTSITE CIRCULAR OR OVAL-SHAPED? THE NURSE STATED THAT NO PHYSICAL DAMAGE WAS OBSERVED. PLEASE PROVIDE DETAILS OF THE STORAGE CONDITIONS PRIOR TO USE I.E., WHERE ARE THE PRODUCTS STORED? IS THE AREA TEMPERATURE CONTROLLED? THE PRODUCTS WERE STORED IN WAREHOUSES AT ROOM TEMPERATURE.
NO ADDITIONAL INFORMATION.
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 145570 | BD ALARIS SMARTSITE NEEDLE-FREE VALVE | INTRAVASCULAR ADMINISTRATION SET | FPA | BECTON DICKINSON | 1030534 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |