BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES

    MDR report key: 9660913 · Received February 3, 2020

    Report

    Report Number
    1917413-2020-00067
    Event Type
    Malfunction
    Date Received
    February 3, 2020
    Date of Event
    January 9, 2020
    Report Date
    February 26, 2020
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903630832
    PMA / PMN Number
    K013971
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR OVERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR TESTING AND UPON COMPLETION, NO ISSUES WERE OBSERVED RELATING TO OVERFILL AS ALL SAMPLES MET SPECIFICATIONS. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TUBES ARE OVER FILLING WITH A BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES. THIS OCCURRED ON (B)(4) SEPARATE OCCASIONS DURING USE WITH BATCH # 9260290, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ((B)(4) OF (B)(4) COMPLAINTS) IT WAS REPORTED THAT CITRATE TUBES ARE OVERFILLING. ADDITIONALLY THE SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: HOW MANY TUBES WERE WITNESSED OVERFILLING FROM EACH LOT NUMBER REPORTED? CONSISTENTLY WITH EACH DRAW. 9260290 AND 9260286 ARE PATIENT IDENTIFIERS KNOWN? IF SO, PLEASE PROVIDE (GENDER, AGE, DOB, WEIGHT, ETC.) NO SPECIFICS HOW WAS THE TUBE REJECTED (I.E.: AT THE COLLECTION, BY THE LAB, BY AUTOMATED FILL LEVEL SENSING, ETC.)? FIRST FROM LAB, THEN STAFF WOULD NOT SEND DUE TO VISUALLY PAST THE TOP FILL ACCEPTANCE LEVEL (PAST WAY PAST THE SUGGESTED FILL LINE) HOW WAS THE TUBE DRAWN? FROM IV START USING THE VACUTAINER WITH THE ADAPTER TO PULL FROM LOOP WAS A DISCARD TUBE USED? SOMETIMES IF THERE WAS FLUID IN THE LOOP, BUT NO IF WAS DRAWN FROM HUB OR NO PREFILLED LOOP WAS A SUCCESSFUL DRAW ACHIEVED WITH THE SAME LOT? YES, BECAUSE NURSE WATCHED VERY CAREFULLY AND DISCONNECTED PRIOR TO OVERFILL IS THIS HAPPENING WITH ONE PARTICULAR: DEPARTMENT, UNIT, AND SHIFT, TIME OF DAY OR PERSON? EMERGENCY WHAT WAS METHOD OF DRAW? STRAIGHT NEEDLE WINGSET SYRINGE X LINE UNSURE/OTHER (PLEASE LIST) IV LINE, BUT INITIAL START ARE YOU USING A BD DEVICE TO TRANSFER THE BLOOD TO A TUBE? BTD LLAD X NO, OTHER DRAWING DIRECTLY INT O THE BLOOD TUBE NO SYRINGE IF USING A WINGSET WERE THE FITTING TIGHT/SECURE? (CONNECTION BETWEEN THREADING LUER ADAPTOR TO HOLDER AND MALE TO FEMALE CONNECTION) HAVE THE TUBES BEEN EXPOSED TO EXTREME HEAT ¿YES X NO

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9260286. MEDICAL DEVICE EXPIRATION DATE: 2020-06-30. DEVICE MANUFACTURE DATE: 2019-09-17. MEDICAL DEVICE LOT #: 9260290. MEDICAL DEVICE EXPIRATION DATE: 2020-06-30. DEVICE MANUFACTURE DATE: 2019-09-17." 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 TUBES ARE OVER FILLING WITH A BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES. THIS OCCURRED ON 20 SEPARATE OCCASIONS DURING USE WITH BATCH # 9260290, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1 OF 3 COMPLAINTS) IT WAS REPORTED THAT CITRATE TUBES ARE OVERFILLING. ADDITIONALLY THE SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: HOW MANY TUBES WERE WITNESSED OVERFILLING FROM EACH LOT NUMBER REPORTED? CONSISTENTLY WITH EACH DRAW. 9260290 AND 9260286. ARE PATIENT IDENTIFIERS KNOWN? IF SO, PLEASE PROVIDE (GENDER, AGE, DOB, WEIGHT, ETC.) NO SPECIFICS. HOW WAS THE TUBE REJECTED (I.E.: AT THE COLLECTION, BY THE LAB, BY AUTOMATED FILL LEVEL SENSING, ETC.)? FIRST FROM LAB, THEN STAFF WOULD NOT SEND DUE TO VISUALLY PAST THE TOP FILL ACCEPTANCE LEVEL (PAST WAY PAST THE SUGGESTED FILL LINE). HOW WAS THE TUBE DRAWN? FROM IV START USING THE VACUTAINER WITH THE ADAPTER TO PULL FROM LOOP. WAS A DISCARD TUBE USED? SOMETIMES IF THERE WAS FLUID IN THE LOOP, BUT NO IF WAS DRAWN FROM HUB OR NO PREFILLED LOOP. WAS A SUCCESSFUL DRAW ACHIEVED WITH THE SAME LOT? YES, BECAUSE NURSE WATCHED VERY CAREFULLY AND DISCONNECTED PRIOR TO OVERFILL. IS THIS HAPPENING WITH ONE PARTICULAR: DEPARTMENT, UNIT, AND SHIFT, TIME OF DAY OR PERSON? EMERGENCY. WHAT WAS METHOD OF DRAW? STRAIGHT NEEDLE, WINGSET, SYRINGE, X LINE, UNSURE/OTHER (PLEASE LIST) IV LINE, BUT INITIAL START. ARE YOU USING A BD DEVICE TO TRANSFER THE BLOOD TO A TUBE? BTD, LLAD, X NO, OTHER DRAWING DIRECTLY INT O THE BLOOD TUBE NO SYRINGE. IF USING A WINGSET WERE THE FITTING TIGHT/SECURE? (CONNECTION BETWEEN THREADING LUER ADAPTOR TO HOLDER AND MALE TO FEMALE CONNECTION). HAVE THE TUBES BEEN EXPOSED TO EXTREME HEAT? YES. X NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126280 BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 363083 SEE H.10 50382903630832

    Patients

    Seq Age Sex Outcome Treatment
    1 Other