BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE CLIPPING DEVICE SAFE CLIP

    MDR report key: 12423811 · Received September 3, 2021

    Report

    Report Number
    2243072-2021-02238
    Event Type
    Malfunction
    Date Received
    September 3, 2021
    Date of Event
    August 5, 2021
    Report Date
    September 23, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903282357
    PMA / PMN Number
    K943683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED TWO SAFECLIP PEN NEEDLE CLIPPERS FROM LOT 9142026. THE FIRST SAFECLIP DID NOT FEATURE ANY IMMEDIATELY OBSERVABLE DEFECTS. TESTING IT ON A PEN NEEDLE FOUND THAT IT WAS CAPABLE OF TRIMMING THE CANNULA OF A PEN NEEDLE WITHOUT ISSUE. NEEDLE BREAK WAS CLEAN AND IMMEDIATELY NEXT TO ITS BASE. THE SECOND SAFECLIP FEATURED A SIGNIFICANT AMOUNT OF RUST BUILDUP AROUND THE MOUTH OF THE TRIMMER. CLOSE INSPECTION OF INSIDE OF THE TRIMMER AT THE MOUTH FOUND MULTIPLE FORMERLY TRIMMED NEEDLES, INDICATING THAT THE DEVICE HAD BEEN USED NUMEROUS TIMES. IT WAS NOTABLY DIFFICULT TO INSERT THE NEEDLE OF THE TRIMMER DURING TESTING. THE DEVICE WAS ALSO NOT CAPABLE OF BREAKING THE CANNULA OFF CLEANLY FROM THE PEN NEEDLE. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. BASED ON THE SAMPLES RECEIVED, BD WAS ABLE TO REPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF THE SAFECLIP NOT TRIMMING NEEDLES IN ONE OF THE TWO RETURNED SAMPLES. THE ROOT CAUSE OF THE SAFECLIP BEING UNABLE TO TRIM NEEDLES MAY BE SIGNIFICANT WEAR AND TEAR OVER TIME. THE SAFECLIP HAS RUSTED AND HAS BEEN FILLED WITH TRIMMED NEEDLES OVER THIS TIME, MAKING TRIMMING THE NEEDLES CLEANLY MORE DIFFICULT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD NEEDLE CLIPPING DEVICE SAFE CLIPS WERE NOT CLIPPING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER :   THE CONSUMER REPORTED THE PRODUCT IS NOT CLIPPING. DATE OF EVENT : UNKNOWN. SAMPLES : YES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE MANUFACTURING LOCATION FOR THIS PRODUCT IS DC US FOUR OAKS. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS : LOT # : 9142026: DEVICE EXPIRATION DATE : NA. DEVICE MANUFACTURE DATE : 06/14/2019. LOT # : UNKNOWN: DEVICE EXPIRATION DATE : UNKNOWN. DEVICE MANUFACTURE DATE : UNKNOWN. 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 2 BD NEEDLE CLIPPING DEVICE SAFE CLIPS WERE NOT CLIPPING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:   THE CONSUMER REPORTED THE PRODUCT IS NOT CLIPPING. DATE OF EVENT : UNKNOWN. SAMPLES: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1318946 NEEDLE CLIPPING DEVICE SAFE CLIP HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 328235 SEE H.10 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1