BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    23 G X .75 IN. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 7011370 · Received November 8, 2017

    Report

    Report Number
    1024879-2017-00192
    Event Type
    Malfunction
    Date Received
    November 8, 2017
    Date of Event
    November 29, 2015
    Report Date
    October 19, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903673426
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: PHOTO INSPECTION OF THE RETURNED CUSTOMER SAMPLE IDENTIFIED SEVERED TUBING. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5240654. CONCLUSION: IN REVIEW OF PUSH BUTTON ASSEMBLY, IT WAS FOUND THAT MULTIVAC KNIVES WERE CUTTING INTO THE BLISTER PACKAGES AND PRODUCTS DURING THE SEALING PROCESS. IN REVIEW OF HISTORICAL PIR DATA, THIS APPEARS TO BE AN ISOLATED INCIDENT AND NOT TYPICAL OF THE OVERALL BATCH QUALITY. CAPA (B)(4) HAS BEEN INITIATED TO DOCUMENT THE INVESTIGATION PATH, ROOT CAUSE ANALYSIS AND REMEDIATION PLAN TO INCLUDE CORRECTIVE AND PREVENTIVE ACTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A COMPLETE AND PARTIAL SET OF THE 23 G X .75 IN. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH 12 IN. TUBING AND LUER ADAPTER'S' TUBING WAS INCLUDED IN A SINGLE PACKAGE. THIS RESULTED IN AN INCOMPLETE SEAL, COMPROMISING STERILITY. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788479 23 G X .75 IN. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD COLLECTION SET JKA BECTON, DICKINSON & CO., (BD) 5240654 50382903673426

    Patients

    Seq Age Sex Outcome Treatment
    1 Other