BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROTAINER® SST¿

    MDR report key: 8475792 · Received April 2, 2019

    Report

    Report Number
    2618282-2019-00156
    Event Type
    Malfunction
    Date Received
    April 2, 2019
    Date of Event
    March 19, 2019
    Report Date
    April 29, 2019
    Manufacturer
    BD CARIBE LTD.
    Product Code
    JKA
    UDI-DI
    50382903659673
    PMA / PMN Number
    K991702
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR UNDERFILL AND POOR BARRIER SEPARATION WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, NO ISSUES WERE OBSERVED RELATING TO UNDERFILL AND POOR BARRIER SEPARATION AS ALL SAMPLES MET SPECIFICATIONS. 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 AND RETAIN SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR UNDERFILL AND POOR BARRIER SEPARATION WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL SAMPLES MET THE REQUIRED SPECIFICATIONS. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. THE PRODUCT WAS FOUND TO BE IN CONFORMANCE AND MEET RELEASE SPECIFICATIONS. RATIONALE: 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 FOUR BD MICROTAINER® SST¿ HAD ISSUES WITH POOR BARRIER SEPARATION AND UNDERFILL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿ HELLO, WELL THINGS HAVE PROGRESSED SINCE LAST WEEK. I BELIEVE (B)(6) ALREADY SENT YOU BACK SOME TUBES FROM FIRST AFFECTED LOT. SINCE THEN WE HAVE FOUND ANOTHER THREE LOTS SO MAY NEED A LITTLE ASSISTANCE FROM BD ON THIS. I DO HAVE ONE UNUSED PACKING LABEL IF YOU WISH THAT WE TRY TO SEND MULTIPLE LOT EXAMPLES, OR JUST WAIT TO HEAR BACK REGARDING A POTENTIAL SHIPPING TEMPERATURE ISSUE. LOTS SO FAR SEEM TO BE 8292794, 8255914, 8347813, AND 8220938. I HAVE NO CONFIRMATION THAT THIS OCCURRED, JUST THINKING YOU WOULD HAVE SEEN THIS AND KNOW WHAT TO LOOK FOR. IT COMES TO MIND AS THIS IS AN ISSUE WITH OTHER REAGENTS IN THE WINTER. IF NOT, WE CAN AT LEAST RULE IT OUT. IT WAS QUITE COLD THIS WINTER AND EVEN OVER THE PAST FEW WEEKS. SOME OF THESE TUBES HAVE BEEN CENTRIFUGED A NUMBER OF TIMES AND STILL NOT WORK APPROPRIATELY, ALTHOUGH IT IS SPORADIC. IN ONE INSTANCE THE CORVAC ENDED UP TOWARD THE TUBE CAP AND WAS IN MAY PIECES. ADDITIONAL INFORMATION RECEIVED: WE COULD NEVER TEST FROM THE PRIMARY TUBE DUE TO LACK OF SAMPLE VOLUME DUE TO LACK OF GEL SEPARATION. WHEN THE TUBES SPIN THERE IS A SMALL RED BUTTON ON THE VERY BOTTOM, WITH GEL JUST ABOVE, THEN A ¿RED¿ LAYER OF CELLS AND DEBRIS ON TOP OF THE GEL. WE HAD TO REMOVE AS MUCH OF THE CELLS AND SERUM AS POSSIBLE FROM THE PRIMARY TUBE AND THEN SPIN THAT AND SEPARATE INTO ANOTHER PLAIN TUBE FOR TESTING. ¿

    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 FOUR BD MICROTAINER® SST¿ HAD ISSUES WITH POOR BARRIER SEPARATION AND UNDERFILL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿ HELLO, WELL THINGS HAVE PROGRESSED SINCE LAST WEEK. I BELIEVE (B)(6) ALREADY SENT YOU BACK SOME TUBES FROM FIRST AFFECTED LOT. SINCE THEN WE HAVE FOUND ANOTHER THREE LOTS SO MAY NEED A LITTLE ASSISTANCE FROM BD ON THIS. I DO HAVE ONE UNUSED PACKING LABEL IF YOU WISH THAT WE TRY TO SEND MULTIPLE LOT EXAMPLES, OR JUST WAIT TO HEAR BACK REGARDING A POTENTIAL SHIPPING TEMPERATURE ISSUE. LOTS SO FAR SEEM TO BE 8292794, 8255914, 8347813, AND 8220938. I HAVE NO CONFIRMATION THAT THIS OCCURRED, JUST THINKING YOU WOULD HAVE SEEN THIS AND KNOW WHAT TO LOOK FOR. IT COMES TO MIND AS THIS IS AN ISSUE WITH OTHER REAGENTS IN THE WINTER. IF NOT, WE CAN AT LEAST RULE IT OUT. IT WAS QUITE COLD THIS WINTER AND EVEN OVER THE PAST FEW WEEKS. SOME OF THESE TUBES HAVE BEEN CENTRIFUGED A NUMBER OF TIMES AND STILL NOT WORK APPROPRIATELY, ALTHOUGH IT IS SPORADIC. IN ONE INSTANCE THE CORVAC ENDED UP TOWARD THE TUBE CAP AND WAS IN MAY PIECES. ADDITIONAL INFORMATION RECEIVED: WE COULD NEVER TEST FROM THE PRIMARY TUBE DUE TO LACK OF SAMPLE VOLUME DUE TO LACK OF GEL SEPARATION. WHEN THE TUBES SPIN THERE IS A SMALL RED BUTTON ON THE VERY BOTTOM, WITH GEL JUST ABOVE, THEN A ¿RED¿ LAYER OF CELLS AND DEBRIS ON TOP OF THE GEL. WE HAD TO REMOVE AS MUCH OF THE CELLS AND SERUM AS POSSIBLE FROM THE PRIMARY TUBE AND THEN SPIN THAT AND SEPARATE INTO ANOTHER PLAIN TUBE FOR TESTING. ¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269706 BD MICROTAINER® SST¿ BLOOD SPECIMEN COLLECTION DEVICE JKA BD CARIBE LTD. 8220938 50382903659673

    Patients

    Seq Age Sex Outcome Treatment
    1 Other