BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE CLIPPING DEVICE SAFE CLIP

    MDR report key: 10237720 · Received July 6, 2020

    Report

    Report Number
    2243072-2020-01006
    Event Type
    Malfunction
    Date Received
    July 6, 2020
    Date of Event
    June 15, 2020
    Report Date
    August 12, 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

    H.6. INVESTIGATION SUMMARY NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED AS OF (B)(6) 2020 THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. ACCORDING WITH THE DHR REVIEW INFORMATION ATTACHED 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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVALUATION?: YES. D.10. RETURNED TO MANUFACTURER ON: (B)(6)2020. H.6. INVESTIGATION: CUSTOMER RETURNED ONE (1) USED BD SAFECLIP DEVICE FROM LOT 9120021. CONSUMER REPORTED THAT HER SAFE CLIP NEEDLE CLIPPER JAMS WHILE CLIPPING THE NEEDLE. THE RETURNED SAFE CLIP WAS EXAMINED MICROSCOPICALLY, AND IT WAS OBSERVED THAT THE CUTTING HOLE WAS BLOCKED BY CANNULA CUT FROM PREVIOUS USAGE. CANNULAS WERE NOT ABLE TO BE CUT USING THE RETURNED SAFE-CLIP. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED ON THIS SAMPLE. SINCE THE SAMPLE WAS RETURNED AFTER USE, AND NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED, THE PROBABLE CAUSE OF THE BLOCKAGE IN THE SAFECLIP IS USER ERROR WHEN USING THE DEVICE. 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 THE NEEDLE CLIPPING DEVICE SAFE CLIP JAMMED DURING USE WHILE CLIPPING THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED THAT HER SAFE CLIP NEEDLE CLIPPER JAMS WHILE CLIPPING THE NEEDLE. CONSUMER STATED THAT THE DEVICE ONLY HAS A FEW NEEDLES INSIDE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE CLIPPING DEVICE SAFE CLIP JAMMED DURING USE WHILE CLIPPING THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED THAT HER SAFE CLIP NEEDLE CLIPPER JAMS WHILE CLIPPING THE NEEDLE. CONSUMER STATED THAT THE DEVICE ONLY HAS A FEW NEEDLES INSIDE.".

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). 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. 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 THE NEEDLE CLIPPING DEVICE SAFE CLIP JAMMED DURING USE WHILE CLIPPING THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED THAT HER SAFE CLIP NEEDLE CLIPPER JAMS WHILE CLIPPING THE NEEDLE. CONSUMER STATED THAT THE DEVICE ONLY HAS A FEW NEEDLES INSIDE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696067 NEEDLE CLIPPING DEVICE SAFE CLIP HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 328235 9120021 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1 Other