BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 7635381 · Received June 25, 2018

    Report

    Report Number
    1911916-2018-00322
    Event Type
    Malfunction
    Date Received
    June 25, 2018
    Date of Event
    June 5, 2018
    Report Date
    August 22, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051220
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCH, INCLUDING NO NOTIFICATION WRITTEN FOR THE CANNULA COMPONENT BATCHES EITHER, SPECIFICALLY FOR BENT. ASSEMBLY BATCH 7114954 HAD 88 VISUAL INSPECTIONS PERFORMED ON 4,550 PARTS WITH ZERO DEFECTS NOTED. THE EPOXY DETECTION SYSTEM WAS CHALLENGED 21 TIMES USING 525 PARTS WITH ZERO FAILURES RECORDED. THIRTEEN CANNULA REMOVAL FORCE TESTS WERE PERFORMED ON 65 SAMPLES WITH A MINIMUM REMOVAL FORCE OF 11 LBS., A MAXIMUM REMOVAL FORCE OF 26 LBS., AND AN AVERAGE REMOVAL FORCE OF 19.5 LBS. THE SPECIFICATION LIMIT FOR CANNULA REMOVAL FORCES FOR A 25 GAUGE NEEDLE IS A MINIMUM OF 5.0 LBS. CANNULA BATCHES 7219732, 7221869, 7221877 AND 7229922 WERE ALSO REVIEWED FOR BENT. 25GA IS CHALLENGED FOR REVERSALS (NUMBER OF TIMES TO BEND/BREAK) ON A SKIP LOT BASIS. THE 25GA PRODUCT HAS TO MEET THE ISO REQUIREMENTS AND CANNULA HAS HAD NO REJECTIONS FOR 25GA REVERSALS FOR THE SEVEN YEARS OF DATA STORED. THE SKIP LOT CONTINUES AS LONG AS THERE ARE NOT FAILURES TO THE SPECIFICATIONS. INVESTIGATION CONCLUSION: UNABLE TO DETERMINE A ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING A BD PRECISIONGLIDE¿ NEEDLE ON A CAT, WHEN PULLING OUT THE NEEDLE IT STAYED INSIDE OF THE ANIMAL AND ¿THEY COULDN¿T GET THE NEEDLE OUT¿. THEY DID NOT REPORT ANY MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN USING A BD PRECISIONGLIDE¿ NEEDLE ON A CAT, WHEN PULLING OUT THE NEEDLE IT STAYED INSIDE OF THE ANIMAL AND ¿THEY COULDN¿T GET THE NEEDLE OUT¿. THEY DID NOT REPORT ANY MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475371 BD PRECISIONGLIDE¿ NEEDLE NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 7138961 30382903051220

    Patients

    Seq Age Sex Outcome Treatment
    1 Other