BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA

    MDR report key: 8760439 · Received July 3, 2019

    Report

    Report Number
    2243072-2019-01328
    Event Type
    Malfunction
    Date Received
    July 3, 2019
    Date of Event
    June 12, 2019
    Report Date
    July 16, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    K093972
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: MATERIAL NO. 363706, BATCH NO. UNKNOWN. -IT WAS REPORTED THAT DURING USE OF THE BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA THE TUBES WERE OVER FILLING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I¿M WRITING BECAUSE THE NURSING STAFF IN OUR NEONATAL UNIT HAVE NOTICED AN INCREASE IN SPECIMENS BEING CLOTTED SINCE WE STARTED THE NEW EDTA MAP TUBES LAST MONTH. I DID MENTION THAT NOTHING WAS DIFFERENT BETWEEN THIS TUBE AND THE PREVIOUS PEDIATRIC TUBE (IE; EDTA CONCENTRATION) AND THEY HAVEN¿T CHANGED THEIR TECHNIQUE AT ALL. D.1. MEDICAL DEVICE BRAND NAME: BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA D.2. MEDICAL DEVICE TYPE: JKA D.4. MEDICAL DEVICE CATALOG #: 363706. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.5. PMA / 510(K)#: K093972. H.6. INVESTIGATION: INVESTIGATION SUMMARY: AS BD HAD NOT RECEIVED ANY SAMPLE, PHOTO, AND/OR LOT NUMBER FROM THE CUSTOMER FACILITY FOR EVALUATION, AN INVESTIGATION COULD NOT BE PERFORMED AS NO INFORMATION WAS AVAILABLE FOR REVIEW. INVESTIGATION CONCLUSION: AS BD HAD NOT RECEIVED ANY SAMPLE, PHOTO, AND/OR LOT NUMBER FROM THE CUSTOMER FACILITY FOR EVALUATION, AN INVESTIGATION COULD NOT BE PERFORMED AS NO INFORMATION WAS AVAILABLE FOR REVIEW. ROOT CAUSE DESCRIPTION: AS THERE WAS NO SAMPLE OR PHOTO AVAILABLE FOR EVALUATION, A ROOT CAUSE COULD NOT BE DETERMINED. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    MATERIAL NO. 363706, BATCH NO. UNKNOWN. -IT WAS REPORTED THAT DURING USE OF THE BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA THE TUBES WERE OVER FILLING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I¿M WRITING BECAUSE THE NURSING STAFF IN OUR NEONATAL UNIT HAVE NOTICED AN INCREASE IN SPECIMENS BEING CLOTTED SINCE WE STARTED THE NEW EDTA MAP TUBES LAST MONTH. I DID MENTION THAT NOTHING WAS DIFFERENT BETWEEN THIS TUBE AND THE PREVIOUS PEDIATRIC TUBE (IE; EDTA CONCENTRATION) AND THEY HAVEN¿T CHANGED THEIR TECHNIQUE AT ALL.

    Additional Manufacturer Narrative · 1

    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. (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE EVALUATED BY MFR: 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

    MATERIAL NO. UNKNOWN, BATCH NO. UNKNOWN. IT WAS REPORTED THAT DURING USE OF THE UNSPECIFIED BD¿ TUBES THE TUBES WERE OVER FILLING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I¿M WRITING BECAUSE THE NURSING STAFF IN OUR NEONATAL UNIT HAVE NOTICED AN INCREASE IN SPECIMENS BEING CLOTTED SINCE WE STARTED THE NEW EDTA MAP TUBES LAST MONTH. I DID MENTION THAT NOTHING WAS DIFFERENT BETWEEN THIS TUBE AND THE PREVIOUS PEDIATRIC TUBE (IE; EDTA CONCENTRATION) AND THEY HAVEN¿T CHANGED THEIR TECHNIQUE AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555182 BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other