BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFE-CLIP¿

    MDR report key: 16212623 · Received January 19, 2023

    Report

    Report Number
    2243072-2023-00044
    Event Type
    Malfunction
    Date Received
    January 19, 2023
    Date of Event
    January 2, 2023
    Report Date
    March 17, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903282357
    PMA / PMN Number
    K943683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS NYPRO. THIS SITE IS AN OEM MANUFACTURING SITE. (B)(4). MEDICAL DEVICE EXPIRATION DATE: NA. INITIAL REPORTER NAME AND ADDRESS: ADDRESS INFORMATION WAS NOT ABLE TO BE OBTAINED, THEREFORE, NJ WAS USED AS A PLACE HOLDER.

    Additional Manufacturer Narrative · 0

    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 02-FEB-2023. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) USED BD SAFECLIP FROM LOT# 2031001. THE CUSTOMER REPORTED THAT NEEDLE CLIP IS NOT CLIPPING CAUSING NEEDLES TO DROP. THE RETURNED SAMPLE WAS EXAMINED, AND IT WAS OBSERVED THAT THE CUTTER HOLE WAS BLOCKED WITH PREVIOUSLY CLIPPED CANNULA ADDITIONAL CANNULA COULD NOT BE INSERTED INTO THE RECEPTACLE DUE TO THE BLOCKAGE. 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. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS THE DEVICE PERFORMED AS INTENDED AND IS NOW LIKELY FULL. THE CAUSE FOR THIS ISSUE IS USER RELATED. THE SAFECLIP PERFORMED AS INTENDED, AND IS NOW LIKELY FULL. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SAFE-CLIP¿ IT WAS JAMMING AND NOT PROPERLY CLIPPING. THIS OCCURRED TWICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER MAYBE 500 NEEDLES THE OPENING GETS JAMMED AND WILL NO LONGER SNIP NEEDLES. THEY REMAIN STUCK IN THE ENTRY CAUSING ME TO DROP NEEDLE TIPS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SAFE-CLIP¿ IT WAS JAMMING AND NOT PROPERLY CLIPPING. THIS OCCURRED TWICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER MAYBE 500 NEEDLES THE OPENING GETS JAMMED AND WILL NO LONGER SNIP NEEDLES. THEY REMAIN STUCK IN THE ENTRY CAUSING ME TO DROP NEEDLE TIPS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SAFE-CLIP¿ IT WAS JAMMING AND NOT PROPERLY CLIPPING. THIS OCCURRED TWICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER MAYBE 500 NEEDLES THE OPENING GETS JAMMED AND WILL NO LONGER SNIP NEEDLES. THEY REMAIN STUCK IN THE ENTRY CAUSING ME TO DROP NEEDLE TIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395034 BD SAFE-CLIP¿ HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 328235 2031001 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown