BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN(LH) 83 UNITS BLOOD COLLECTION TUBES

    MDR report key: 8875238 · Received August 8, 2019

    Report

    Report Number
    1917413-2019-01886
    Event Type
    Malfunction
    Date Received
    August 8, 2019
    Date of Event
    July 24, 2019
    Report Date
    August 29, 2019
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903679626
    PMA / PMN Number
    K945952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. 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. TO ASSURE A HIGH QUALITY SPECIMEN WHEN UTILIZING HEPARIN PLASMA, SEVERAL FACTORS ARE KEY. INCLUDED, BUT NOT LIMITED TO ARE: PROPER PHLEBOTOMY TECHNIQUE TO MINIMIZE POOR BARRIER SEPARATION AND PLATELET ACTIVATION, PROPER TUBE FILL VOLUME TO ASSURE THE PROPER BLOOD-TO-ADDITIVE RATION, GENTLE AND THOROUGH MIXING, PROPER CENTRIFUGATION CONDITIONS-G FORCE AND TIME, AND STORAGE CONDITIONS. EVALUATION AND ENFORCEMENT OF ¿ADD ON TESTING¿ POLICIES AND VALIDATION OF ANALYTE STABILITY, INCLUDING THE EFFECTS OF SPECIMENS CONTAINING LATENT FIBRIN SHOULD BE CONSIDERED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN(LH) 83 UNITS BLOOD COLLECTION TUBES HAD POOR BARRIER SEPARATION. THIS WAS DISCOVERED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367962, BATCH NO. UNKNOWN, EXP: NOV 2019, 9095790, EXP: APR 2020. IT WAS REPORTED THAT THERE WAS POOR BARRIER SEPARATION AFTER CENTRIFUGE. POOR SEPARATION AFTER CENTRIFUGE. OCCURRENCE QTY IS NOT AVAILABLE. 80% OF THE PRODUCT WAS AFFECTED NO PATIENT IDENTIFIERS. NO DATES OF EVENTS. CUSTOMER STATES THAT THEY ARE SEEING RBC'S IN GEL AND THAT THERE IS A LAYER ABOVE GEL OF CONTAMINANTS?. THEY CURRENTLY SPIN AT 3600 G'S FOR 10 MINUTES, THIS IS ABOVE OUR RECOMMENDATION. THEY DO NOT REFRIGERATE THE SPECIMENS. THEY DO NOT KNOW HOW MANY TIMES THE TUBES ARE INVERTED AFTER COLLECTION. THEY HAVE HAD ERRONEOUS RESULTS FOR PSA TESTING. COULD NOT GATHER FURTHER INFORMATION AT THIS TIME AS CALL WAS DISCONNECTED, TRIED CALLING NUMBER PROVIDED AND IT IS A NON-WORKING NUMBER.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9095790, MEDICAL DEVICE EXPIRATION DATE: 2020-04-30, DEVICE MANUFACTURE DATE: 2019-04-05. MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. DEVICE EVALUATED BY MFR: 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® PST¿ GEL AND LITHIUM HEPARIN (LH) 83 UNITS BLOOD COLLECTION TUBES HAD POOR BARRIER SEPARATION. THIS WAS DISCOVERED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367962, BATCH NO. UNKNOWN EXP NOV 2019, 9095790 EXP APR 2020. IT WAS REPORTED THAT THERE WAS POOR BARRIER SEPARATION AFTER CENTRIFUGE. POOR SEPARATION AFTER CENTRIFUGE. OCCURRENCE QTY IS NOT AVAILABLE. 80% OF THE PRODUCT WAS AFFECTED. NO PATIENT IDENTIFIERS. NO DATES OF EVENTS. CUSTOMER STATES THAT THEY ARE SEEING RBC'S IN GEL AND THAT THERE IS A LAYER ABOVE GEL OF CONTAMINANTS. THEY CURRENTLY SPIN AT 3600 G'S FOR 10 MINUTES, THIS IS ABOVE OUR RECOMMENDATION. THEY DO NOT REFRIGERATE THE SPECIMENS. THEY DO NOT KNOW HOW MANY TIMES THE TUBES ARE INVERTED AFTER COLLECTION. THEY HAVE HAD ERRONEOUS RESULTS FOR PSA TESTING. COULD NOT GATHER FURTHER INFORMATION AT THIS TIME AS CALL WAS DISCONNECTED, TRIED CALLING NUMBER PROVIDED AND IT IS A NON-WORKING NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671149 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN(LH) 83 UNITS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) SEE H.10 50382903679626

    Patients

    Seq Age Sex Outcome Treatment
    1 Other