BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 8103006 · Received November 26, 2018

    Report

    Report Number
    1213809-2018-00819
    Event Type
    Malfunction
    Date Received
    November 26, 2018
    Date of Event
    November 6, 2018
    Report Date
    February 7, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096320
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A TOTAL OF 478 SAMPLES IN 2 OPENED AND 3 SEALED SHELF CARTONS WERE RECEIVED, CONTAINING SEALED PACKAGED PRODUCT CONFIRMED TO BE FROM BATCH #8243753 (P/N 309632). THE SAMPLES WERE VISUALLY EVALUATED. 252 PACKAGES CONTAINED NO FOREIGN MATTER. 162 PACKAGES CONTAINED SMALL LOOSE BLACK FOREIGN MATTER SPECKS INSIDE THE PACKAGES OUTSIDE THE FLUID PATH. THE FOREIGN MATTER IN THESE PACKAGES WAS SMALLER THAN LEVEL 3 IN SIZE AND ACCEPTABLE PER PRODUCT SPECIFICATION. 64 PACKAGES WERE FOUND TO CONTAIN FOREIGN MATTER PARTICLES LARGER THAN LEVEL 3 IN SIZE WHICH ARE REJECTABLE PER PRODUCT SPECIFICATION. THE PARTICLES WERE INSIDE THE PACKAGES OUTSIDE THE FLUID PATH. ALL OF THE AFFECTED PACKAGES WERE FROM CAVITIES 1 THROUGH 8. PER FOURIER TRANSFORM INFRARED ANALYSIS THE FOREIGN MATTER WAS IDENTIFIED TO BE MOST LIKELY POLYETHYLENE. THE PACKAGING CAVITIES 1 THROUGH 8 ARE ALL PACKAGED ON ONE SIDE OF THE PACKAGING MACHINE. THE PACKAGING PROCESS WAS THOROUGHLY EVALUATED FOR ANY ABNORMALITIES. A HARD POLYETHYLENE CABLE WRAP WAS IDENTIFIED AS A POTENTIAL SOURCE OF THE FOREIGN MATTER AS IT INTERACTS WITH A MACHINE GUARD. THE WRAP WAS BEING DAMAGED THROUGH FRICTION WITH THE GUARD EDGE, CREATING PARTICULATES IN THE PROCESS. THE PARTICULATES COULD THEN COLLECT ON THE GUARD AND BE INADVERTENTLY INTRODUCED INTO PACKAGES DURING ANY HUMAN INTERVENTION IN THAT AREA OF THE MACHINE. POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER PARTICULATE IS LIKELY ASSOCIATED WITH THE POLYETHYLENE CABLE WRAP MATERIAL AND ITS SETUP. CORRECTIVE ACTION: (1) THE IMMEDIATE SETUP WAS CORRECTED TO REDUCE FRICTION. (2) POLYETHYLENE CABLE WRAP WILL BE REPLACED WITH HIGH DENSITY POLYETHYLENE MATERIAL. (3) THE SETUP OF THE CABLES WILL BE IMPROVED TO GREATLY REDUCE FRICTION TO ELIMINATE OR GREATLY REDUCE PARTICULATE CREATION LONG TERM. A DHR WAS PERFORMED FOR THIS LOT. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 8243753 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE HAD BLACK SPOTS ON THE SEAL.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE HAD BLACK SPOTS ON THE SEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940674 BD SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON MEDICAL SYSTEMS 8243753 30382903096320

    Patients

    Seq Age Sex Outcome Treatment
    1 Other