BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 8782187 · Received July 11, 2019

    Report

    Report Number
    1024879-2019-01170
    Event Type
    Malfunction
    Date Received
    July 11, 2019
    Date of Event
    June 26, 2019
    Report Date
    August 20, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR POOR BARRIER SEPARATION WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, EVALUATION/TESTING OF THE CUSTOMER SAMPLES WAS PERFORMED AND POOR BARRIER SEPARATION WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR POOR BARRIER SEPARATION WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, EVALUATION/TESTING OF THE CUSTOMER SAMPLES WAS CONDUCTED AND POOR BARRIER SEPARATION WAS OBSERVED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES EXPERIENCED POOR BARRIER SEPARATION AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367986, BATCH NO. 9030857. USER FACILITY'S CHEMISTRY LAB IS HAVING TROUBLE WITH ERROR ALERTS ON THEIR NEW ANALYZER. PROBES WERE CHANGED RECENTLY AND NOT AS MANY ALERTS BUT WANTED TO SUBMIT THESE JUST IN CASE. CUSTOMER RESPONSE ON (B)(6) 2019 -THE LOT NUMBER IS 9030857. CUSTOMER RESPONSE ON (B)(6) 2019- ERROR ALERTS? ARE THE TUBES GETTING ERRONEOUS RESULTS? NO ERRONEOUS RESULTS THAT I WAS INFORMED OF. THE ERROR ALERT IS REFERRING TO THE ANALYZER TESTING THE TUBES. AN ¿ABNORMAL ASPIRATION¿ ALERT WOULD COME UP SO THEN THE USER HAD TO STOP THE MACHINE AND CHECK THE TUBE AND SO THE TUBE BECAME SUSPECT IN WHY THE ALERT CAME UP. HOWEVER, SINCE THE PROBES HAVE BEEN CHANGED A WEEK OR SO AGO, THIS PROBLEM HAS BEEN DECREASING. IT IS NOT CLEAR WHETHER THE TUBES ARE AT FAULT OR NEW MACHINERY OR PREANALYTICAL HANDLING CONDITIONS. MANAGEMENT WILL WORK WITH THEIR STAFF AND REMIND THEM TO FOLLOW BEST PRACTICE INCLUDING FULL CLOTTING TIME AND REQUIRED INVERSIONS AFTER COLLECTION. IS IT ONLY THESE 4 TUBES AFFECTED? MORE THAN THE 4 TUBES WERE AFFECTED. THE DAY I WAS THERE THOUGH, THOSE WERE THE ONES THEY HAD THAT WERE SHOWN TO ME. WHAT DATE WAS THIS? WEDNESDAY (B)(6) SO THAT IS THE DAY BD WAS INFORMED BUT IN TALKING WITH THE TECH II SHE STATED THAT THIS WAS HAPPENING FOR ¿A WHILE¿. WHAT EXACTLY DO YOU MEAN BY ¿QUESTIONABLE APPEARANCE¿? SOME OF THE TUBES DID NOT APPEAR ¿PERFECTLY SEPARATED ¿(COULD BE THERE WAS GEL ON THE SIDE AT THE BOTTOM OR A BIT OF RED CELLS ON THE GEL OR INCOMPLETE SEPARATION OF RED BLOOD CELLS AND SERUM)."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 4 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES EXPERIENCED POOR BARRIER SEPARATION AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367986, BATCH NO. 9030857. USER FACILITY'S CHEMISTRY LAB IS HAVING TROUBLE WITH ERROR ALERTS ON THEIR NEW ANALYZER. PROBES WERE CHANGED RECENTLY AND NOT AS MANY ALERTS BUT WANTED TO SUBMIT THESE JUST IN CASE. CUSTOMER RESPONSE 07/08/2019: THE LOT NUMBER IS 9030857. CUSTOMER RESPONSE 06/28/2019: ERROR ALERTS? ARE THE TUBES GETTING ERRONEOUS RESULTS? NO ERRONEOUS RESULTS THAT I WAS INFORMED OF. THE ERROR ALERT IS REFERRING TO THE ANALYZER TESTING THE TUBES. AN ¿ABNORMAL ASPIRATION¿ ALERT WOULD COME UP SO THEN THE USER HAD TO STOP THE MACHINE AND CHECK THE TUBE AND SO THE TUBE BECAME SUSPECT IN WHY THE ALERT CAME UP. HOWEVER, SINCE THE PROBES HAVE BEEN CHANGED A WEEK OR SO AGO, THIS PROBLEM HAS BEEN DECREASING. IT IS NOT CLEAR WHETHER THE TUBES ARE AT FAULT OR NEW MACHINERY OR PREANALYTICAL HANDLING CONDITIONS. MANAGEMENT WILL WORK WITH THEIR STAFF AND REMIND THEM TO FOLLOW BEST PRACTICE INCLUDING FULL CLOTTING TIME AND REQUIRED INVERSIONS AFTER COLLECTION. IS IT ONLY THESE 4 TUBES AFFECTED? MORE THAN THE 4 TUBES WERE AFFECTED. THE DAY I WAS THERE THOUGH, THOSE WERE THE ONES THEY HAD THAT WERE SHOWN TO ME. WHAT DATE WAS THIS? WEDNESDAY (B)(6) SO THAT IS THE DAY BD WAS INFORMED BUT IN TALKING WITH THE TECH II SHE STATED THAT THIS WAS HAPPENING FOR ¿A WHILE¿. WHAT EXACTLY DO YOU MEAN BY ¿QUESTIONABLE APPEARANCE¿? SOME OF THE TUBES DID NOT APPEAR ¿PERFECTLY SEPARATED ¿(COULD BE THERE WAS GEL ON THE SIDE AT THE BOTTOM OR A BIT OF RED CELLS ON THE GEL OR INCOMPLETE SEPARATION OF RED BLOOD CELLS AND SERUM)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575428 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 9030857 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other