BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 9687819 · Received February 10, 2020

    Report

    Report Number
    1024879-2020-00073
    Event Type
    Malfunction
    Date Received
    February 10, 2020
    Date of Event
    January 21, 2020
    Report Date
    April 23, 2020
    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
    CO
    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 UNDERFILL WITH THE INCIDENT LOT WAS OBSERVED. THE CUSTOMER SAMPLES WERE TESTED AND NO ISSUES RELATING TO UNDERFILL WERE OBSERVED AS ALL RESULTS DEMONSTRATED SATISFACTORY PERFORMANCE. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SAMPLING THE TUBES ARE UNDER FILLING WITH A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: AT THE TIME OF SAMPLING, THE TUBE DOES NOT HAVE FULL SAMPLE FILLING AND SOMETIMES IT DOES NOT FILL ANYTHING. ADDITIONALLY, ON 2020-02-04 THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: HOW MANY UNITS (TUBES) AFFECTED? - 15. WHAT IS THE FREQUENCY OR OCCURRENCE RATE (1 DAY, % OF TUBES AFFECTED, PATIENTS INVOLVED, HOW MANY TEST PER DAY ETC.) - 6 PATIENTS. WHAT IS THE LABELED DRAW VOLUME (2ML, 3MLETC) - 5 ML. WHAT WAS THE LEVEL OF TUBE FILL? X NO FILL (FILL VOLUME IS NEAR ZERO). PARTIAL FILL. OVER FILL. UNSURE. HOW WAS THE TUBE REJECTED (I.E.: AT THE COLLECTION, BY THE LAB, BY AUTOMATED FILL LEVEL SENSING, ETC.)? - IT WAS DISCARDED BY THE LABORATORY WHEN THE TUBE NOT FILL WHAT WAS THE TUBE¿S EXPIRATION DATE?: LOT 9143650 - 05-31-2020. LOT9059681 - 2-29-2020. LOT 9067617 - 2-29-2020. LOT 9219329 - 7-31-2020. HOW WAS THE TUBE DRAWN? WAS A DISCARD TUBE USED? - NO. WAS A SUCCESSFUL DRAW ACHIEVED WITH THE SAME LOT? - YES. IS THIS HAPPENING WITH ONE PARTICULAR: DEPARTMENT, UNIT, AND SHIFT, TIME OF DAY OR PERSON? - NO. WHAT WAS METHOD OF DRAW? STRAIGHT NEEDLE. WINGSET. SYRINGE. LINE. X UNSURE/OTHER (PLEASE LIST) - BD VACUTAINER NEEDLE. ARE YOU USING A BD DEVICE TO TRANSFER THE BLOOD TO A TUBE? BTD. LLAD. X NO, OTHER. IF USING A WINGSET WERE THE FITTING TIGHT/SECURE? (CONNECTION BETWEEN THREADING LUER ADAPTOR TO HOLDER AND MALE TO FEMALE CONNECTION) - NO. HAVE THE TUBES BEEN EXPOSED TO EXTREME HEAT YES. X NO. UNSURE. HOW MANY LOCATIONS AFFECTED (IMPATIENT, OUTPATIENTS, ETC.) - ONLY ONE.

    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 #: 9059681. MEDICAL DEVICE EXPIRATION DATE: 2020-02-29. DEVICE MANUFACTURE DATE: 2019-02-28. MEDICAL DEVICE LOT #: 9067617. MEDICAL DEVICE EXPIRATION DATE: 2020-02-29. DEVICE MANUFACTURE DATE: 2019-03-08. MEDICAL DEVICE LOT #: 9143650. MEDICAL DEVICE EXPIRATION DATE: 2020-05-31. DEVICE MANUFACTURE DATE: 2019-05-23. " A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SAMPLING THE TUBES ARE UNDER FILLING WITH A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: AT THE TIME OF SAMPLING, THE TUBE DOES NOT HAVE FULL SAMPLE FILLING AND SOMETIMES IT DOES NOT FILL ANYTHING. ADDITIONALLY, ON 2020-02-04 THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: HOW MANY UNITS (TUBES) AFFECTED? 15. WHAT IS THE FREQUENCY OR OCCURRENCE RATE (1 DAY, % OF TUBES AFFECTED, PATIENTS INVOLVED, HOW MANY TEST PER DAY ETC.) 6 PATIENTS. WHAT IS THE LABELED DRAW VOLUME (2ML, 3MLETC)? 5 ML. WHAT WAS THE LEVEL OF TUBE FILL? X NO FILL (FILL VOLUME IS NEAR ZERO). PARTIAL FILL. OVER FILL. UNSURE. HOW WAS THE TUBE REJECTED (I.E.: AT THE COLLECTION, BY THE LAB, BY AUTOMATED FILL LEVEL SENSING, ETC.)? IT WAS DISCARDED BY THE LABORATORY WHEN THE TUBE NOT FILL WHAT WAS THE TUBE¿S EXPIRATION DATE?: LOT 9143650 - 05-31-2020. LOT9059681 - 2-29-2020. LOT 9067617 - 2-29-2020. LOT 9219329 - 7-31-2020. HOW WAS THE TUBE DRAWN? WAS A DISCARD TUBE USED? NO. WAS A SUCCESSFUL DRAW ACHIEVED WITH THE SAME LOT? YES. IS THIS HAPPENING WITH ONE PARTICULAR: DEPARTMENT, UNIT, AND SHIFT, TIME OF DAY OR PERSON? NO. WHAT WAS METHOD OF DRAW? STRAIGHT NEEDLE. WINGSET. SYRINGE. LINE. X UNSURE/OTHER (PLEASE LIST) BD VACUTAINER NEEDLE ARE YOU USING A BD DEVICE TO TRANSFER THE BLOOD TO A TUBE? BTD. LLAD. X NO, OTHER. IF USING A WINGSET WERE THE FITTING TIGHT/SECURE? (CONNECTION BETWEEN THREADING LUER ADAPTOR TO HOLDER AND MALE TO FEMALE CONNECTION) NO. HAVE THE TUBES BEEN EXPOSED TO EXTREME HEAT YES. X NO. UNSURE. HOW MANY LOCATIONS AFFECTED (IMPATIENT, OUTPATIENTS, ETC.) ONLY ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154242 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367986 SEE H.10 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other