BD ALARIS SMARTSITE EXTENSION SET
Report
- Report Number
- 9616066-2022-00535
- Event Type
- Malfunction
- Date Received
- May 6, 2022
- Date of Event
- April 14, 2022
- Report Date
- July 20, 2022
- Manufacturer
- SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
- Product Code
- FPA
- UDI-DI
- 27613203013820
- PMA / PMN Number
- K960280
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 14-JUL-2022. H6: INVESTIGATION SUMMARY: SEVENTY-FIVE 20039E SAMPLES AND TWENTY-FIVE BD VACUTAINER SAMPLES WERE RECEIVED IN SEALED PACKAGING FOR INVESTIGATION. FOR THE RETURNED 20039E PRODUCTS, TWENTY-FIVE SAMPLES WERE FROM LOT 21085559, TWENTY-FIVE WERE FROM LOT 21085567, TWENTY-FOUR WERE FROM LOT 21075174 AND ONE SAMPLE WAS FROM LOT 21085801. FOR THE RETURNED BD VACUTAINER PRODUCTS, ONE SAMPLE WAS FROM LOT 1130027 AND TWENTY-FOUR WERE FROM LOT 1172450. THE FEEDBACK PROVIDED BY THE CUSTOMER INDICATES THAT A COMPLETE OCCLUSION WAS DETECTED WHEN THE VACUTAINER WAS CONNECTED TO THE 20039E EXTENSION SET AS NO BLOOD WAS ABLE TO BE DRAWN FROM THE PATIENT; HOWEVER, THE CUSTOMER INDICATED THAT NO OCCLUSIONS WERE DETECTED WHEN USING A SYRINGE AS THE CONNECTING PRODUCT. FUNCTIONAL TESTING WAS PERFORMED BY CONNECTING THE BD VACUTAINER TO THE 20039E EXTENSION SET AND FLUSHING THROUGH WITH FLUID USING A 50ML BD PLASTIPAK SYRINGE. TESTING WAS PERFORMED ON ONE SAMPLE FROM LOT 21085801, AND FIVE SAMPLES EACH FROM LOTS 21085559, 21085567 AND 21075174; IN EACH INSTANCE, NO OCCLUSIONS OR FLOW RESTRICTIONS WERE DETECTED AS THE PISTON OF THE SMARTSITE COMPONENT OPENED, AND THE VACUTAINER VIAL WAS FILLED WITH FLUID. A VISUAL INSPECTION OF THE RETURNED SAMPLES DID NOT REVEAL ANY DEFECTS OR DAMAGE WHICH COULD HAVE CONTRIBUTED TO THE CUSTOMER'S EXPERIENCE. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOTS 21085801, 21085559, 21085567, 21075174 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. IT WAS NOT POSSIBLE TO CONFIRM THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE IN THIS INSTANCE, AS TESTING OF THE RETURNED SAMPLES DID NOT IDENTIFY ANY PRODUCT DEFECTS OR QUALITY DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE. 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 OCCLUSION. H3 OTHER TEXT : SEE H10.
H6: INVESTIGATION SUMMARY A 20039E PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLE WAS FROM LOT 21085801. FURTHER INFORMATION PROVIDED BY THE CUSTOMER APPEARS TO INDICATE THAT THE OCCLUSION OCCURRED UPON CONNECTION TO A BD VACUTAINER PRODUCT. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 21085801DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED AS THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. IN THIS INSTANCE, WITHOUT A SAMPLE IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED FAULT.
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OCCLUSION WITH LLAD, CAN¿T TAKE BLOOD SAMPLE, BUT OK WITH SYRINGE.
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OCCLUSION WITH LLAD, CAN'T TAKE BLOOD SAMPLE, BUT OK WITH SYRINGE.
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OCCLUSION WITH LLAD, CAN¿T TAKE BLOOD SAMPLE, BUT OK WITH SYRINGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1079235 | BD ALARIS SMARTSITE EXTENSION SET | INTRAVASCULAR ADMINISTRATION SET | FPA | SISTEMAS MEDICOS ALARIS, S.A. DE C.V. | 20039E | 21085801 | 27613203013820 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |