BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® TUBE GLU PLH 13X75 4.0 BLBLCE GR

    MDR report key: 17752962 · Received September 14, 2023

    Report

    Report Number
    1917413-2023-00899
    Event Type
    Malfunction
    Date Received
    September 14, 2023
    Date of Event
    August 24, 2023
    Report Date
    September 29, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. 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

    H.6. INVESTIGATION SUMMARY: BD DID NOT RECEIVE SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 100 RETENTIONS WERE VISUALLY INSPECTED WITH THE HEMOGARD CLOSURE ASSEMBLY CORRECTLY ASSEMBLED AND PLACED ON THE TUBES. THERE WERE NO COCKED STOPPERS IDENTIFIED THAT WOULD CAUSE THE HEMOGARD CLOSURE ASSEMBLY TO NOT BE APPLIED CORRECTLY. IN ADDITION, 10 RETENTION SAMPLES WERE DRAW-TESTED WITH ALL WEIGHTS BEING WITHIN SPECIFICATION LIMITS. NO ISSUES WITH THE HEMOGARD CLOSURE ASSEMBLY BEING LOOSE OR SEPARATING DURING OR AFTER THE DRAW TESTING WAS COMPLETED. 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. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE OF TUBE PUSH-OFF. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® TUBE GLU PLH 13X75 4.0 BLBLCE GR TUBE IS PUSHING OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: BD TUBES FLYING OFF THE NON-PATIENT END OF THE NEEDLE IN HOLDER INCLUDING: 367839 - X1 BATCH 3009574, 367935 - X1 BATCH 2200184, 367958 - X1 BATCH 2304762.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® TUBE GLU PLH 13X75 4.0 BLBLCE GR TUBE IS PUSHING OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: BD TUBES FLYING OFF THE NON-PATIENT END OF THE NEEDLE IN HOLDER INCLUDING: 367839 - X1 BATCH 3009574, 367935 - X1 BATCH 2200184, 367958 - X1 BATCH 2304762.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303945 BD VACUTAINER® TUBE GLU PLH 13X75 4.0 BLBLCE GR BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 2200184

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown