BD SMARTSITE¿ NEEDLE-FREE VALVE
Report
- Report Number
- 9616066-2023-01940
- Event Type
- Malfunction
- Date Received
- September 25, 2023
- Date of Event
- August 5, 2023
- Report Date
- October 4, 2023
- Manufacturer
- SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
- Product Code
- FPA
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.6. INVESTIGATION SUMMARY: NO SAMPLES WERE RECEIVED FOR INVESTIGATION OF PR 8840124, IN WHICH THE CUSTOMER HAS STATED: "WHEN THEY ATTACH THE BUNG TO THE CANNULA THEY ARE BACK FLOWING AND CAUSING INCREASED PRESSURE AND BLEEDING." THIS FEEDBACK IS IN REFERENCE TO 2000E7D PRODUCTS FROM LOT 1024444. FURTHER CORRESPONDENCE WITH THE CUSTOMER CLARIFIED THE ISSUE FURTHER, AS IT WAS STATED: "THE STAFF WERE FLUSHING THE BUNGS ON ALL 3X OCCASIONS AND THE SYRINGES OF N.SALINE WERE FILLING UP WITH BLOOD." THERE WERE NO REPORTS OF ANY DAMAGE OR DEFORMITY TO THE SMARTSITE COMPONENTS. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 1024444 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE CAUSED OR CONTRIBUTED TO A REPORT OF THIS NATURE. PLEASE NOTE THAT THE 2000E7D PRODUCT IS NOT A BACK CHECK VALVE AND THEREFORE DURING USE IT MAY BE POSSIBLE FOR BACK FLOW TO OCCUR UNDER CERTAIN INFUSION RATES AND CLINICAL SET-UPS. WHEN THE SMARTSITE COMPONENT IS ACCESSED WITH A COMPATIBLE MALE LUER, IT IS EFFECTIVELY AN OPEN PATH, THROUGH WHICH FLUID CAN TRAVEL IN BOTH DIRECTIONS; HOWEVER, WHEN THE CONNECTING PRODUCT IS REMOVED, IT BECOMES A CLOSED SYSTEM. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT COMPLAINTS OF THIS NATURE ARE RARE AND THERE IS CURRENTLY NO TREND FOR ISSUES OF THIS NATURE AGAINST THE 2000E7D PRODUCT.
H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT THE BD SMARTSITE¿ NEEDLE-FREE VALVE CAUSED BLOOD TO BACK-FLOW DURING THE INFUSION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "STAFF IN MEDICAL DECISIONS UNIT AT HOSPITAL DESCRIBE THREE SEPERATE INCIDENTS WHEN THEY ATTACH THE BUNG TO THE CANNULA THEY ARE BACK FLOWING AND CAUSING INCREASED PRESSURE AND BLEEDING. THREE INCIDENTS OCCURED OVER 24 HOURS ON (B)(6) 23. STAFF UTILISED USS AND PATHOLOGY GAS ANALYSIS TO RULE OUT THE LIKELY HOOD OR ARTERIAL CANNULATION INSTEAD OF VENOUS. ON EACH OCCASION IT WAS A VEIN THAT WAS CANNULATED. NO INJURY TO STAFF OR PATIENTS REPORTED OR BLOOD EXPOSURE INCIDENTS."
IT WAS REPORTED THAT THE BD SMARTSITE¿ NEEDLE-FREE VALVE CAUSED BLOOD TO BACK-FLOW DURING THE INFUSION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "STAFF IN MEDICAL DECISIONS UNIT AT HOSPITAL DESCRIBE THREE SEPERATE INCIDENTS WHEN THEY ATTACH THE BUNG TO THE CANNULA THEY ARE BACK FLOWING AND CAUSING INCREASED PRESSURE AND BLEEDING. THREE INCIDENTS OCCURED OVER 24 HOURS ON (B)(6) 2023. STAFF UTILISED USS AND PATHOLOGY GAS ANALYSIS TO RULE OUT THE LIKELY HOOD OR ARTERIAL CANNULATION INSTEAD OF VENOUS. ON EACH OCCASION IT WAS A VEIN THAT WAS CANNULATED. NO INJURY TO STAFF OR PATIENTS REPORTED OR BLOOD EXPOSURE INCIDENTS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1881253 | BD SMARTSITE¿ NEEDLE-FREE VALVE | INTRAVASCULAR ADMINISTRATION SET | FPA | SISTEMAS MEDICOS ALARIS, S.A. DE C.V. | 1024444 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |