BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD COLLECTION TUBES

    MDR report key: 11697281 · Received April 20, 2021

    Report

    Report Number
    1917413-2021-00295
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    March 24, 2021
    Report Date
    May 10, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903678865
    PMA / PMN Number
    K945952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES D.10. RETURNED TO MANUFACTURER ON: 4/22/2021 H.6. INVESTIGATION: BD RECEIVED 6 SAMPLES AND 5 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR UNDERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLES ALONG WITH 10 RETENTION SAMPLES FROM BD INVENTORY, WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO UNDERFILL AS ALL SAMPLES MET SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD COLLECTION TUBES UNDERFILLED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " SO I AM EMAILING IN REGARDS TO THE LITHIUM HEPARIN TUBES WE USE FOR OUR QUANTIFERON TESTING. THIS PARTICULAR TEST REQUIRES A FULL 6ML WHOLE BLOOD SAMPLE. OUR TECHS NOTICED TODAY THAT THE TUBES ARE NOT FILLING TO THE FILL LINE. THE TECH HAD A GOOD BLEEDER AND THE TUBE WOULD NOT FILL COMPLETELY. SO I HAD THE TECH GET SOME WATER AND SEE IF THAT WOULD FILL TO THE TOP AND IT DID NOT. THE WATER FILLED THE SAME AMOUNT AS DID THE BLOOD. THE LOT# IS: 0072519 EXP: 8-31-2021 WITH THE TUBES NOT FILLING COMPLETELY WE ARE HAVING TO CANCEL AND RECOLLECT MULTIPLE PATIENTS PUTTING UNDUE BURDEN ON THE PATIENTS (HAVING TO BE REDRAWN, DRIVING TO AN OUTREACH DRAW SITE, TIME OUT OF THEIR DAY, EXTRA TECH TIME AND SUPPLIES, ETC). I DID NOT KNOW IF YOU HAD ANY OTHER COMPLAINTS PERTAINING TO THESE TUBES. PLEASE LET ME KNOW HOW YOU WOULD LIKE ME TO PROCEED WITH THIS ISSUE. I APPRECIATE YOUR TIME AND HELP. I LOOK FORWARD TO HEARING BACK FROM YOU. THANKS IN ADVANCE AND MUCH APPRECIATED"

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD COLLECTION TUBES UNDERFILLED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " SO I AM EMAILING IN REGARDS TO THE LITHIUM HEPARIN TUBES WE USE FOR OUR QUANTIFERON TESTING. THIS PARTICULAR TEST REQUIRES A FULL 6ML WHOLE BLOOD SAMPLE. OUR TECHS NOTICED TODAY THAT THE TUBES ARE NOT FILLING TO THE FILL LINE. THE TECH HAD A GOOD BLEEDER AND THE TUBE WOULD NOT FILL COMPLETELY. SO I HAD THE TECH GET SOME WATER AND SEE IF THAT WOULD FILL TO THE TOP AND IT DID NOT. THE WATER FILLED THE SAME AMOUNT AS DID THE BLOOD. THE LOT# IS: 0072519, EXP: 8-31-2021. WITH THE TUBES NOT FILLING COMPLETELY WE ARE HAVING TO CANCEL AND RECOLLECT MULTIPLE PATIENTS PUTTING UNDUE BURDEN ON THE PATIENTS (HAVING TO BE REDRAWN, DRIVING TO AN OUTREACH DRAW SITE, TIME OUT OF THEIR DAY, EXTRA TECH TIME AND SUPPLIES, ETC). I DID NOT KNOW IF YOU HAD ANY OTHER COMPLAINTS PERTAINING TO THESE TUBES. PLEASE LET ME KNOW HOW YOU WOULD LIKE ME TO PROCEED WITH THIS ISSUE. I APPRECIATE YOUR TIME AND HELP. I LOOK FORWARD TO HEARING BACK FROM YOU. THANKS IN ADVANCE AND MUCH APPRECIATED"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592471 BD VACUTAINER LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367886 0072519 50382903678865

    Patients

    Seq Age Sex Outcome Treatment
    1