BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFE-CLIP

    MDR report key: 10301971 · Received July 21, 2020

    Report

    Report Number
    2243072-2020-01091
    Event Type
    Malfunction
    Date Received
    July 21, 2020
    Date of Event
    June 30, 2020
    Report Date
    August 11, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903282357
    PMA / PMN Number
    K943683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES D.10. RETURNED TO MANUFACTURER ON: 7/29/2020 H.6. INVESTIGATION: CUSTOMER RETURNED ONE (1) USED BD SAFECLIP DEVICE FROM LOT 9120021. CONSUMER REPORTED THE "SAFECLIP" IS NOT CLIPPING HER NEEDLES; CONSUMER ALSO REPORTED SHE'S TRYING TO CLIP A 26G. THE RETURNED SAFE CLIP WAS EXAMINED MICROSCOPICALLY AND IT WAS OBSERVED THAT THE CUTTING HOLE WAS 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. ADDITIONALLY, AS PER IFU, THE SAFE-CLIP DEVICE IS NOT INTENDED TO BE USED WITH LANCETS OR CANNULA LARGER THAN 28G. IF THE CUSTOMER USED THE SAFE-CLIP DEVICE ON LANCETS OR CANNULA LARGER THAN 28G, THE CUTTER BLADE COULD BE DAMAGED. ACCORDING WITH THE DHR REVIEW INFORMATION 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=1).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE THE SAFECLIP IS NOT CLIPPING NEEDLES WITH A BD SAFE-CLIP¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE "SAFECLIP" IS NOT CLIPPING HER NEEDLES. SHE'S TRYING TO CLIP A 26G. EXPLAINED, SAFE CLIP CAN BE USED WITH 28-32G ONLY.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE THE SAFECLIP IS NOT CLIPPING NEEDLES WITH A BD SAFE-CLIP¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE "SAFECLIP" IS NOT CLIPPING HER NEEDLES. SHE'S TRYING TO CLIP A 26G. EXPLAINED, SAFE CLIP CAN BE USED WITH 28-32G ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770164 BD SAFE-CLIP HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 328235 9120021 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1 Other