BD ALARIS SMARTSITE NEEDLE-FREE VALVE
Report
- Report Number
- 9616066-2024-02039
- Event Type
- Malfunction
- Date Received
- December 12, 2024
- Date of Event
- December 1, 2024
- Report Date
- February 13, 2025
- Manufacturer
- SISTEMAS MEDICOS ALARIS S.A. DE C.V.
- Product Code
- FPA
- UDI-DI
- 07613203011938
- PMA / PMN Number
- K223088
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
TWO 2000E SAMPLES WERE RECEIVED FOR INVESTIGATION OF PR (B)(4), IN WHICH THE CUSTOMER HAS STATED: "SMARTSITE'S BLUE PISTON IS OCCLUSION." OF THE TWO SAMPLES PROVIDED BY THE CUSTOMER, ONE WAS RECEIVED CONNECTED TO A 3ML BD POSIFLUSH SYRINGE (LOT 4080318); NO PACKAGING WAS RECEIVED FOR EITHER PRODUCT. THE SECOND 2000E PRODUCT WAS RECEIVED IN SEALED PACKAGING FROM LOT 24045685. THE RETURNED SAMPLES WERE SUBJECTED TO FUNCTIONAL TESTING BY PRIMING AND FLUSHING USING A 50ML BD PLASTIPAK SYRINGE. FOR BOTH SAMPLES, NO FLOW ISSUES WERE OBSERVED THROUGHOUT TESTING AS FLUID COULD BE BOTH DRAWN UP AND EXPELLED UNIMPEDED. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. IN THIS INSTANCE, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED AS TESTING OF THE RETURNED SAMPLES DID NOT IDENTIFY ANY PRODUCT DEFECTS OR QUALITY DEVIATION THAT COULD HAVE CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 24045685 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. ALTHOUGH IT WAS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER'S EXPERIENCE, THE QUALITY TEAM AT THE MANUFACTURING SITE HAS BEEN INFORMED OF THIS COMPLAINT IN ORDER TO BE AWARE OF THE REPORTED FAILURE MODE DURING FUTURE PRODUCTION OF THIS PRODUCT. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS A RARE OCCURRENCE WITH A SMALL NUMBER OF SIMILAR REPORTS AGAINST THE PRODUCT 2000E IN THE PAST 12 MONTHS.
A 2000E PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION OF (B)(4) ; HOWEVER, THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLE WAS FROM LOT 24045685. THE FEEDBACK PROVIDED BY THE CUSTOMER STATES THAT, "SMARTSITE'S BLUE PISTON IS OCCLUSION." NO FURTHER INFORMATION WAS AVAILABLE TO ASSIST THE INVESTIGATION IN THIS INSTANCE. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION, WHERE A REVIEW OF THE PRODUCTION RECORDS FOR LOT 24045685 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE CAUSED OR CONTRIBUTED TO A REPORT OF THIS NATURE. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED IN THIS INSTANCE AS NO SAMPLE WAS RECEIVED FOR INVESTIGATION. WITHOUT A SAMPLE TO EXAMINE IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO A REPORT OF THIS NATURE. HOWEVER, PREVIOUS COMPLAINTS FOR OCCLUSIONS HAVE BEEN RELATED TO FEATURES ON THE SURFACE OF THE MALE LUER OF THE CONNECTING PRODUCTS. THESE FEATURES INCLUDE FLASH OR A RAISED EDGE TO THE TIP OF THE MALE LUER WHICH HAVE PREVIOUSLY BEEN SHOWN TO INTERMITTENTLY LEAD TO RESTRICTED FLOW DUE TO THEM PINCHING THE BLUE PISTON OF THE SMARTSITE® AND NOT ALLOWING IT TO OPEN. THIS CAN SOMETIMES BE RESOLVED BY DISCONNECTING AND REATTACHING THE SAME LUER CONNECTION WHICH MAY REPOSITION THE LUER AGAINST THE PISTON AND IMPROVE THE FLOW, OR ALTERNATIVELY BY CHANGING THE CONNECTING MALE LUER. IN THIS INSTANCE, WITHOUT THE COMPLAINT SAMPLE TO EXAMINE IT HAS NOT BEEN POSSIBLE TO CONCLUSIVELY LINK THIS FEEDBACK TO A SPECIFIC FAILURE MODE; HOWEVER, A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS A RARE OCCURRENCE WITH A SMALL NUMBER OF SIMILAR REPORTS AGAINST THE PRODUCT 2000E IN THE PAST 12 MONTHS.
IT WAS REPORTED THAT BD ALARIS SMARTSITE NEEDLE-FREE VALVE WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING SMARTSITE'S BLUE PISTON IS OCCLUSION.
NO ADDITIONAL INFORMATION.
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1905414 | BD ALARIS SMARTSITE NEEDLE-FREE VALVE | INTRAVASCULAR ADMINISTRATION SET | FPA | SISTEMAS MEDICOS ALARIS S.A. DE C.V. | 24045685 | 07613203011938 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |