BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFE-CLIP

    MDR report key: 10457649 · Received August 26, 2020

    Report

    Report Number
    2243072-2020-01313
    Event Type
    Malfunction
    Date Received
    August 26, 2020
    Date of Event
    August 5, 2020
    Report Date
    September 23, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903282357
    PMA / PMN Number
    K943683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED ONE (1) USED BD SAFECLIP DEVICE FROM LOT 9142026. CONSUMER REPORTED JUST JAMS THE NEEDLE WILL NOT ACCEPT IT OR CLIP THE NEEDLE. THE RETURNED SAFE CLIP WAS EXAMINED MICROSCOPICALLY AND EXHIBITED DRY BLOOD NEAR THE CUTTING HOLE; THE CUTTING HOLE WAS ALSO 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 WITH THE DHR REVIEW INFORMATION ATTACHED (SEE ATTACHED FILE), THE PROBLEM ¿NO 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). H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD SAFE-CLIPS¿ EXPERIENCED THE SAFECLIP NOT CLIPPING/JAMMED. PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328235 BATCH NO: 9142026 CONSUMER REPORTED JUST JAMS THE NEEDLE WILL NOT ACCEPT IT OR CLIP THE NEEDLE. BLACK WITH BLUE SAFE CLIP DEVICE. USING THIS DEVICE ABOUT 2 1/2 MONTHS WITH PEN NEEDLES AND INSULIN SYRINGES. 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. 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: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD SAFE-CLIPS¿ EXPERIENCED THE SAFECLIP NOT CLIPPING/JAMMED. PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328235 BATCH NO: 9142026. CONSUMER REPORTED JUST JAMS THE NEEDLE WILL NOT ACCEPT IT OR CLIP THE NEEDLE. BLACK WITH BLUE SAFE CLIP DEVICE. USING THIS DEVICE ABOUT 2 1/2 MONTHS WITH PEN NEEDLES AND INSULIN SYRINGES. LOT #: 9142026. CATALOG#: 328235. DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922259 BD SAFE-CLIP HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 328235 9142026 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1 Other