BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE POTASSIUM OXALATE

    MDR report key: 11634402 · Received April 8, 2021

    Report

    Report Number
    2243072-2021-01017
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    March 12, 2021
    Report Date
    April 21, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    PMA / PMN Number
    K901449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED, THE FOLLOWING FIELDS HAVE BEEN UPDATED. B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THE USER IDENTIFIED THE BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE: 100MG POTASSIUM OXALATE: 20MG WAS EXPIRED AFTER USE. D1: BRAND NAME: BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE: 100MG, POTASSIUM OXALATE: 20MG, D.3 MEDICAL DEVICE MANUFACTURER: BECTON, DICKINSON & CO. (BROKEN BOW), D.4. MEDICAL DEVICE CATALOG #: 367001, D.4. MEDICAL DEVICE LOT#:UNKNOWN (THE LOT NUMBER PROVIDED DOES NOT MATCH THE DEVICE), D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4), G.1. MANUFACTURING LOCATION: BECTON, DICKINSON & CO. (BROKEN BOW), G.5. PMA / 510(K) #: K901449. H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT, THE LOT NUMBER PROVIDED WAS INCORRECT AS IT DID NOT MATCH THE MATERIAL NUMBER. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. ALL PRODUCTS THAT HAVE AN EXPIRATION DATE APPEARING AS A YEAR/MONTH WILL EXPIRE ON THE LAST DAY OF THE MONTH INDICATED. THIS EXPIRATION DATE APPLIES TO, AND IS TO BE USED BY BD PREANALYTICAL SYSTEMS WAREHOUSES, DISTRIBUTOR WAREHOUSES, AND CUSTOMERS TO DETERMINE WHEN THEIR STOCK INVENTORY EXPIRES. BD DOES NOT RECOMMEND THAT BD VACUTAINER® BRAND TUBES BE USED PAST THE EXPIRATION DATE. THERE IS NO EXTENDED TIME PERIOD PAST THE EXPIRATION DATE DURING WHICH THE TUBES CAN BE USED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THE USER IDENTIFIED THE BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE: 100MG POTASSIUM OXALATE: 20MG WAS EXPIRED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT IS REPORTED CUSTOMER USED AN EXPIRED TUBE. VERBIAGE RECEIVED, - "THIS IS A FOLLOW UP TO OUR CONVERSATION A SHORT TIME AGO. IN SUMMARY, MAY 2020 I COVERED A FATAL CRASH WHERE A PEDESTRIAN WAS KILLED. THE DRIVER WAS GIVEN AN INTOX TEST AND HAD NO ALCOHOL IN HIS SYSTEM. IT WAS DETERMINED HE WAS IMPAIRED AND A BLOOD DRAW WAS DONE WITH A LYNN PEAVEY BLOOD KIT CONTAINING BD VACUUM TUBES. DUE TO AN OVERSIGHT, IT WAS FOUND THE KIT USED WAS EXPIRED (14-15 MONTHS I BELIEVE). THE SUBJECT ADMITTED TO TAKING HIS TWO PRESCRIBED MEDICATIONS THE MORNING OF THE CRASH. WHEN THE LAB RESULTS CAME BACK IT WAS CONFIRMED HE HAD THOSE PRESCRIBED DRUGS IN HIS SYSTEM AS WELL AS ILLEGAL NARCOTICS. THE DEFENSE IS ATTEMPTING TO GET THOSE RESULTS EXCLUDED BASED ON THE EXPIRED KIT. I APPRECIATE YOU ASSISTING IN GETTING ME IN CONTACT WITH THE BEST PERSON TO TALK WITH THIS ISSUE ABOUT. I'M NOT AN EXPERT, BUT I FIND IT UNREASONABLE TO THINK AN EXPIRED VACUUM TUBE (WHICH WAS INSPECTED BY THE BLOOD TECH AND THE LAB WHO NOTED NO ISSUES WITH THE TUBES AND THEY FUNCTIONED PROPERLY) COULD MAGICALLY PRODUCE RESULTS WHICH INCLUDE KNOWN PRESCRIBED MEDICATION AND ILLEGAL NARCOTICS."

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE UNSPECIFIED BD VACUTAINER BLOOD COLLECTION TUBES EXPERIENCED TUBE WAS USED AFTER THE EXPIRATION DATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT IS REPORTED CUSTOMER USED AN EXPIRED TUBE. VERBIAGE RECEIVED, - "THIS IS A FOLLOW UP TO OUR CONVERSATION A SHORT TIME AGO. IN SUMMARY, (B)(6) 2020 I COVERED A FATAL CRASH WHERE A PEDESTRIAN WAS KILLED. THE DRIVER WAS GIVEN AN INTOX TEST AND HAD NO ALCOHOL IN HIS SYSTEM. IT WAS DETERMINED HE WAS IMPAIRED AND A BLOOD DRAW WAS DONE WITH A LYNN PEAVEY BLOOD KIT CONTAINING BD VACUUM TUBES. DUE TO AN OVERSIGHT, IT WAS FOUND THE KIT USED WAS EXPIRED (14-15 MONTHS I BELIEVE). THE SUBJECT ADMITTED TO TAKING HIS TWO PRESCRIBED MEDICATIONS THE MORNING OF THE CRASH. WHEN THE LAB RESULTS CAME BACK IT WAS CONFIRMED HE HAD THOSE PRESCRIBED DRUGS IN HIS SYSTEM AS WELL AS ILLEGAL NARCOTICS. THE DEFENSE IS ATTEMPTING TO GET THOSE RESULTS EXCLUDED BASED ON THE EXPIRED KIT. I APPRECIATE YOU ASSISTING IN GETTING ME IN CONTACT WITH THE BEST PERSON TO TALK WITH THIS ISSUE ABOUT. I'M NOT AN EXPERT, BUT I FIND IT UNREASONABLE TO THINK AN EXPIRED VACUUM TUBE (WHICH WAS INSPECTED BY THE BLOOD TECH AND THE LAB WHO NOTED NO ISSUES WITH THE TUBES AND THEY FUNCTIONED PROPERLY) COULD MAGICALLY PRODUCE RESULTS WHICH INCLUDE KNOWN PRESCRIBED MEDICATION AND ILLEGAL NARCOTICS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534288 BD VACUTAINER BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE POTASSIUM OXALATE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1