BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® URINE COLLECTION CUP

    MDR report key: 12854184 · Received November 22, 2021

    Report

    Report Number
    1917413-2021-01001
    Event Type
    Malfunction
    Date Received
    November 22, 2021
    Date of Event
    October 25, 2021
    Report Date
    January 19, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    KDT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 1/5/2022. H.6. INVESTIGATION: BD RECEIVED NINE (9) SAMPLES FROM LOT 1153536, THREE (3) SAMPLES FROM LOT 1257431, ONE (1) SAMPLE WITH AN UNKNOWN LOT AND SEVEN (7) PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR LEAKAGE OF URINE WAS OBSERVED. THE PHOTOS SHOW A URINE CAP/CUP ASSEMBLY IN BAGS WITH URINE ON THE INSIDE AND OUTSIDE OF THE CUPS. THE PHOTOS ALSO SHOW THE DIFFERENT MOLD NUMBERS OF THE LIDS AND CUPS. THE ROUGH APPEARANCE TO THE LIDS IS BECAUSE THESE LIDS WERE MANUFACTURED ON AN OLDER MOLD THAN THE SMOOTH APPEARING LIDS. THE LIDS HAVE THE SAME DIMENSIONS AND ARE WITHIN SPECIFICATION LIMITS FOR THIS PRODUCT. THE LIDS DO NOT PROVIDE A LIQUID TIGHT BARRIER AND ARE NOT MEANT TO BE ON THEIR SIDE OR SENT THROUGH A PNEUMATIC SYSTEM. ADDITIONALLY, THE CUSTOMER SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND NO DEFECTS WERE OBSERVED THAT COULD CAUSE LEAKAGE OF URINE, AS ALL SAMPLES MET SPECIFICATIONS. THE SAMPLES SHOW CUPS WITH THE LIDS ATTACHED. FOUR (4) LIDS (LOT 1257431/UNKNOWN) HAVE A FROSTED APPEARANCE TO THE TOP OF THE LID AND NINE (9) LIDS (LOT 1153536) APPEAR TO HAVE A SMOOTH APPEARANCE TO THE TOP OF THE LID. THE CUPS AND LIDS DO NOT SHOW ANY ISSUES TO THE THREADS, AS NO VOIDS OR ROUGH AREAS WERE IDENTIFIED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. ALL STERILIZATION RELEASE REVIEWS COMPLY WITH ALL SPECIFICATION REQUIREMENTS. THERE WERE NO RELATED QUALITY NOTIFICATIONS. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE FOR LEAKAGE OF URINE BASED ON THE PHOTOS PROVIDED; HOWEVER, THE LIDS DO NOT PROVIDE A LIQUID TIGHT BARRIER AND ARE NOT MEANT TO BE ON THEIR SIDE OR SENT THROUGH A PNEUMATIC SYSTEM. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION: BD HAD NOT RECEIVED SAMPLES, BUT THREE (3) PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR LEAKAGE OF URINE WAS OBSERVED. THE PHOTOS SHOW URINE CUPS IN PLASTIC BAGS AND THERE IS URINE IN THE CUPS AND THE PLASTIC BAGS. THIS PRODUCT IS NOT INTENDED FOR PNEUMATIC TRANSFER USE. 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 NOTIFICATIONS. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE FOR LEAKAGE OF URINE BASED ON THE PHOTOS PROVIDED. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. H3 OTHER TEXT: SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINE COLLECTION CUP THERE WAS SAMPLE LEAKAGE. THIS EVENT OCCURRED 20 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "DURING USE, THE URINE CUPS WERE LEAKING."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINE COLLECTION CUP THERE WAS SAMPLE LEAKAGE. THIS EVENT OCCURRED 20 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "DURING USE, THE URINE CUPS WERE LEAKING."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINE COLLECTION CUP THERE WAS SAMPLE LEAKAGE. THIS EVENT OCCURRED 20 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "DURING USE, THE URINE CUPS WERE LEAKING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1753726 BD VACUTAINER® URINE COLLECTION CUP SPECIMEN TRANSPORT AND STORAGE CONTAINER KDT BECTON, DICKINSON & CO. (BROKEN BOW) 1153536

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown