BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER URINE ANALYSIS PRESERVATIVE TUBE

    MDR report key: 11311115 · Received February 10, 2021

    Report

    Report Number
    1917413-2021-00084
    Event Type
    Malfunction
    Date Received
    February 10, 2021
    Date of Event
    January 21, 2021
    Report Date
    March 3, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JTW
    UDI-DI
    50382903649926
    PMA / PMN Number
    K790366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED FOUR (4) SAMPLES FROM CATALOG 364992, LOT NUMBER 9344900; TWO (2) SAMPLES FROM CATALOG 364957, LOT NUMBER 0120087 AND TWO (2) SAMPLES FROM CATALOG 364992, LOT NUMBER 0167199 FOR INVESTIGATION. THE SAMPLES WERE EVALUATED BY FUNCTIONAL TESTING AND THE INDICATED FAILURE MODE FOR DRAW VOLUME WITH THE INCIDENT LOT WAS NOT OBSERVED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 0167199. D.4. MEDICAL DEVICE EXPIRATION DATE: 11/30/2021. H.4. DEVICE MANUFACTURE DATE: 6/15/2020. D.4. MEDICAL DEVICE LOT #: 9344900. D.4. MEDICAL DEVICE EXPIRATION DATE: 5/31/2021. H.4. DEVICE MANUFACTURE DATE: 12/10/2019.

    Description of Event or Problem · 0

    THE INITIAL REPORTER EXPERIENCED TEN OCCURRENCES OF UNDERFILL OR LOW DRAW WHEN USING THE BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT IS REPORTED TUBES ARE UNDER FILLING. RECEIVED CALL FROM LABORATORY MANAGER THAT REPORTS FACILITY NOTICING .5 ML AWAY FROM MINIUM FILL LINE. HE STATES ONLY 10 INSTANCES WITHIN A MONTHS TIME. NO SPECIFIC DATE OF EVENT. FACILITY HAS TO RECOLLECT PATIENT'S URINE WITH NO ISSUES. FACILITY IS SITTING AT 7,000 FEET ELEVATION."

    Description of Event or Problem · 0

    THE INITIAL REPORTER EXPERIENCED TEN OCCURRENCES OF UNDERFILL OR LOW DRAW WHEN USING THE BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; "IT IS REPORTED TUBES ARE UNDER FILLING. RECEIVED CALL FROM LABORATORY MANAGER THAT REPORTS FACILITY NOTICING .5 ML AWAY FROM MINIUM FILL LINE. HE STATES ONLY 10 INSTANCES WITHIN A MONTHS TIME. NO SPECIFIC DATE OF EVENT. FACILITY HAS TO RECOLLECT PATIENT'S URINE WITH NO ISSUES. FACILITY IS SITTING AT 7,000 FEET ELEVATION.".

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    THE INITIAL REPORTER EXPERIENCED TEN OCCURRENCES OF UNDERFILL OR LOW DRAW WHEN USING THE BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; "IT IS REPORTED TUBES ARE UNDER FILLING. RECEIVED CALL FROM LABORATORY MANAGER THAT REPORTS FACILITY NOTICING .5 ML AWAY FROM MINIUM FILL LINE. HE STATES ONLY 10 INSTANCES WITHIN A MONTHS TIME. NO SPECIFIC DATE OF EVENT. FACILITY HAS TO RECOLLECT PATIENT'S URINE WITH NO ISSUES. FACILITY IS SITTING AT 7,000 FEET ELEVATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208671 BD VACUTAINER URINE ANALYSIS PRESERVATIVE TUBE SPECIMEN TRANSPORT AND STORAGE CONTAINER JTW BECTON, DICKINSON & CO. (BROKEN BOW) 364992 SEE H.10 50382903649926

    Patients

    Seq Age Sex Outcome Treatment
    1