BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFE-CLIP¿

    MDR report key: 15462303 · Received September 22, 2022

    Report

    Report Number
    2243072-2022-01571
    Event Type
    Malfunction
    Date Received
    September 22, 2022
    Date of Event
    August 25, 2022
    Report Date
    November 4, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903282357
    PMA / PMN Number
    K943683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. (B)(4). 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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2031001, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: 25-FEB-2022. MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) BD SAFECLIP. CUSTOMER STATES THAT THE SAFE CLIPS WERE UNUSABLE AND NOT CLIPPING. THE RETURNED SAMPLE WAS EXAMINED AND EXHIBITED THE CUTTING HOLE BLOCKED WITH CANNULAS AND OTHER MATERIAL. SEE ATTACHED PHOTO. 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. AT THIS POINT THE USER SHOULD DISPOSE THE SAFE CLIP CORRECTLY AS HE OR SHE WOULD FOR ANY FULL SHARPS COLLECTOR/CONTAINER. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE IS USE RELATED AS THIS ISSUE OCCURS DURING NORMAL USE OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD SAFE-CLIPS¿ WOULD NOT CLIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING 3 SAFE CLIPS USABLE FOR ABOUT 1 WEEK. CLIPPING THE BD NANO PEN NEEDLES. CLAIMS YOU CAN SEE THE HOLE IS NOT ALIGNED UP PROPERLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD SAFE-CLIPS¿ WOULD NOT CLIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING 3 SAFE CLIPS USABLE FOR ABOUT 1 WEEK. CLIPPING THE BD NANO PEN NEEDLES. CLAIMS YOU CAN SEE THE HOLE IS NOT ALIGNED UP PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566852 BD SAFE-CLIP¿ HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 328235 SEE H10 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown