BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFE-CLIP

    MDR report key: 10360357 · Received August 3, 2020

    Report

    Report Number
    2243072-2020-01184
    Event Type
    Malfunction
    Date Received
    August 3, 2020
    Date of Event
    July 14, 2020
    Report Date
    August 6, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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 AN UNSPECIFIED NUMBER OF BD SAFE-CLIPS¿ WERE NOT CLIPPING/JAMMED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED SHE PURCHASED TWO NEW BD SAFE-CLIP DEVICES AND THAT ONE OF THEM IS NOT CLIPPING THE NEEDLES AT ALL. STATED SHE ALSO DOESN'T KNOW HOW TO CLIP THE NEEDLES WITH THIS DEVICE. INFORMED CONSUMER OF HOW TO PROPERLY USE THE SAFE-CLIP DEVICE. CONSUMER STATED IT CLIPPED HER 4MM PEN NEEDLE BUT NOT FULLY. SENDING CONSUMER A REPLACEMENT. LG LOT #: 9142026. CATALOG#: 328235. DATE OF EVENT: UNKNOWN.

    Additional Manufacturer Narrative · 1

    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). OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS NYPRO, MX. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD SAFE-CLIPS¿ WERE NOT CLIPPING/JAMMED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED SHE PURCHASED TWO NEW BD SAFE-CLIP DEVICES AND THAT ONE OF THEM IS NOT CLIPPING THE NEEDLES AT ALL. STATED SHE ALSO DOESN'T KNOW HOW TO CLIP THE NEEDLES WITH THIS DEVICE. INFORMED CONSUMER OF HOW TO PROPERLY USE THE SAFE-CLIP DEVICE. CONSUMER STATED IT CLIPPED HER 4MM PEN NEEDLE BUT NOT FULLY. SENDING CONSUMER A REPLACEMENT. LG: LOT #: 9142026, CATALOG#: 328235, DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818698 BD SAFE-CLIP HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 328235 9142026 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1 Other