BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFECLIP¿

    MDR report key: 10048037 · Received May 12, 2020

    Report

    Report Number
    2243072-2020-00752
    Event Type
    Malfunction
    Date Received
    May 12, 2020
    Date of Event
    April 22, 2020
    Report Date
    May 12, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903282357
    PMA / PMN Number
    K943683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY CUSTOMER RETURNED PHOTOS AND A VIDEO OF A BD SAFE CLIP FROM LOT # 4226330. CUSTOMER STATES THAT THERE ARE DIFFICULTIES WITH THE NEEDLE CUTTER, SINCE THE HOLE THROUGH WHICH SHE CUTS THE NEEDLE IS OXIDIZED AND HAS TO MAKE A LOT OF PRESSURE TO BE ABLE TO CUT IT, SHE SAYS THAT ALREADY NEEDLES CANNOT BE CUT. THE PHOTOS AND VIDEO WERE EXAMINED AND EXHIBITED A BUILDUP OF MATERIAL AROUND THE CUTTING HOLE AND A NEEDLE WAS NOT ABLE TO BE INSERTED INTO THE CUTTING HOLE TO BE CUT. THIS INDICATES THAT THE SAFE CLIP IS FULL AND SHOULD BE PROPERLY DISPOSED OF. ACCORDING WITH THE DHR REVIEW INFORMATION ABOVE, THE PROBLEM ¿NOT CLIPPING¿ AND ¿FOREIGN MATTER (RUST)¿ HAS NO NHB ASSEMBLY PROCESS RELATION, ALL SAMPLES OF SAFE CLIP DISPOSABLE CUTTER (USA) PASSED FUNCTIONAL TEST (SAMPLE PLAN C=0 AND AQL=1). BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLES ARE NOT CLIPPING WITH AN BD SAFECLIP¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THE PATIENT'S CAREGIVER IS COMMUNICATED, WHO REPORTS THAT SINCE OCTOBER / 2019 (DATE NOT EXACT) SHE PRESENTS DIFFICULTIES WITH THE NEEDLE CUTTER, SINCE THE HOLE THROUGH WHICH SHE CUTS THE NEEDLE IS OXIDIZED AND HAS TO MAKE A LOT OF PRESSURE TO BE ABLE TO CUT IT, SHE SAYS THAT ALREADY NEEDLES CANNOT BE CUT.

    Additional Manufacturer Narrative · 1

    FOR OEM MANUFACTURING SITES: IN THIS MDR, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AS (B)(4) IS AN OEM MANUFACTURING SITE. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: NA. 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 NEEDLES ARE NOT CLIPPING WITH AN BD SAFECLIP¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THE PATIENT'S CAREGIVER IS COMMUNICATED, WHO REPORTS THAT SINCE (B)(6) 2019 (DATE NOT EXACT) SHE PRESENTS DIFFICULTIES WITH THE NEEDLE CUTTER, SINCE THE HOLE THROUGH WHICH SHE CUTS THE NEEDLE IS OXIDIZED AND HAS TO MAKE A LOT OF PRESSURE TO BE ABLE TO CUT IT, SHE SAYS THAT ALREADY NEEDLES CANNOT BE CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509939 BD SAFECLIP¿ HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 328235 4226330 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1 Other