BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFE-CLIP

    MDR report key: 15432625 · Received September 15, 2022

    Report

    Report Number
    2243072-2022-01522
    Event Type
    Malfunction
    Date Received
    September 15, 2022
    Date of Event
    August 22, 2022
    Report Date
    October 20, 2022
    Manufacturer
    BECTON DICKINSON & COMPANY
    Product Code
    FMI
    UDI-DI
    00382903282357
    PMA / PMN Number
    K943683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9192035, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: 25-JUL-2019, MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL? YES. D10: RETURNED TO MANUFACTURER ON: 12-SEP-2022. H6. INVESTIGATION SUMMARY: CUSTOMER RETURNED (2) BD SAFE CLIPS. CUSTOMER STATES THAT THE SAFE CLIP JAMS AFTER 1-2 WEEKS OF USE. BOTH RETURNED SAMPLES WERE EXAMINED AND BOTH EXHIBITED A CUTTING HOLE BLOCKED WITH CANNULAS. THE MOST LIKELY SCENARIO IS THAT THE SAFE CLIP IS FULL, IT HAS BEEN USED OVER TIME AND THERE IS NO MORE ROOM TO STORE ANY 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. UNABLE TO PERFORM DHR CHECK FOR NOT CLIPPING DUE TO UNKNOWN LOT NUMBER. EMBECTA WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS THIS OCCURS DURING NORMAL USE OF THE PRODUCT. THE ROOT CAUSE FOR THIS ISSUE CANNOT BE DETERMINED AS THE OBSERVED ISSUE OCCURS DURING NORMAL USE OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAFE-CLIP JAMMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING THE SAFE CLIPS JAM AFTER 1-2 WEEKS OF USE HAS 4 DEVICES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAFE-CLIP JAMMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING THE SAFE CLIPS JAM AFTER 1-2 WEEKS OF USE HAS 4 DEVICES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAFE-CLIP JAMMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING THE SAFE CLIPS JAM AFTER 1-2 WEEKS OF USE HAS 4 DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222605 BD SAFE-CLIP HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON & COMPANY 328235 SEE H.10 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown