BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE CLIPPING DEVICE SAFE CLIP

    MDR report key: 10751890 · Received October 28, 2020

    Report

    Report Number
    2243072-2020-01753
    Event Type
    Malfunction
    Date Received
    October 28, 2020
    Date of Event
    October 8, 2020
    Report Date
    November 5, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903282357
    PMA / PMN Number
    K943683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY CUSTOMER RETURNED ONE (1) USED BD SAFE CLIP DEVICE FROM LOT 9120021. NO SAMPLES FROM LOT 9345001 WERE PROVIDED. CONSUMER REPORTED SAFE CLIP IS NOT CLIPPING. SINCE NO SAMPLES FROM LOT 9345001 WERE PROVIDED, THE ALLEGED ISSUE COULD NOT BE CONFIRMED REGARDING LOT 9345001. THE RETURNED SAFE CLIP FROM LOT 9120021 WAS EXAMINED MICROSCOPICALLY AND THE CUTTING HOLE WAS OBSERVED TO BE BLOCKED BY CANNULA CUT FROM PREVIOUS USAGE. CANNULA WERE NOT ABLE TO BE CUT USING THE RETURNED SAFE-CLIP. THE LIKELY SCENARIO IS THAT THE SAFE CLIP IS FULL, HAS BEEN USED OVER TIME, AND THERE IS NO ROOM TO STORE ADDITIONAL CANNULA. THIS USUALLY RESULTS AFTER NORMAL USE OF THE PRODUCT AND IS THEREFORE NOT CONFIRMED AS A DEFECT. AT THIS POINT THE USER SHOULD DISPOSE THE SAFE CLIP CORRECTLY AS HE OR SHE WOULD FOR ANY FULL SHARPS COLLECTOR/CONTAINER. ACCORDING TO THE DHR REVIEW THE PROBLEM ¿NOT CLIPPING¿ HAS NO NHB ASSEMBLY PROCESS RELATION, ALL SAMPLES OF SAFE CLIP DISPOSABLE CUTTER (USA) PASSED FUNCTIONAL TEST (SAMPLE PLAN C=0 AND AQL=0.65).

    Additional Manufacturer Narrative · 0

    CORRECTION: THE CUSTOMER PROVIDED THE INFORMATION FOR AN ADDITIONAL LOT#. THE FOLLOWING FIELDS HAVE BEEN UPDATED: B5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE NEEDLE CLIPPING DEVICE SAFE CLIP STOPPED CLIPPING NEEDLES DURING USE. LOTS 9345001 AND 9120021 WERE EACH REPORTED TO HAVE HAD 1 OCCURRENCE OF THIS EVENT. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 9345001, D.4. MEDICAL DEVICE EXPIRATION DATE: NA, H.4. DEVICE MANUFACTURE DATE: 2020-01-31. D.4. MEDICAL DEVICE LOT #: 9120021, D.4. MEDICAL DEVICE EXPIRATION DATE: NA, H.4. DEVICE MANUFACTURE DATE: 2019-05-13.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE CLIPPING DEVICE SAFE CLIP STOPPED CLIPPING NEEDLES DURING USE. LOTS 9345001 AND 9120021 WERE EACH REPORTED TO HAVE HAD 1 OCCURRENCE OF THIS EVENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED SAFE CLIP IS NOT CLIPPING".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE CLIPPING DEVICE SAFE CLIP STOPPED CLIPPING NEEDLES DURING USE. LOTS 9345001 AND 9120021 WERE EACH REPORTED TO HAVE HAD 1 OCCURRENCE OF THIS EVENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED SAFE CLIP IS NOT CLIPPING."

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE CLIPPING DEVICE SAFE CLIP STOPPED CLIPPING NEEDLES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED SAFE CLIP IS NOT CLIPPING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217703 NEEDLE CLIPPING DEVICE SAFE CLIP HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 328235 SEE SECTION H.10. 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1