BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE CLIPPING DEVICE SAFE CLIP

    MDR report key: 10032920 · Received May 7, 2020

    Report

    Report Number
    2243072-2020-00732
    Event Type
    Malfunction
    Date Received
    May 7, 2020
    Date of Event
    April 17, 2020
    Report Date
    July 28, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    K943683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.2 COMMON DEVICE NAME: HYPODERMIC SINGLE LUMEN NEEDLE. D.4 MEDICAL DEVICE CATALOG # 328235. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 9120021. D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.4. DEVICE MANUFACTURE DATE: 2019-05-13. D.4. MEDICAL DEVICE LOT #: 9134024. D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.4. DEVICE MANUFACTURE DATE: 2019-05-25. D.4 UNIQUE IDENTIFIER (UDI) # (B)(4). D.10 DEVICE AVAILABLE FOR EVAL YES. D.10 RETURNED TO MANUFACTURER ON: 2020-07-13. G.5 PMA / 510(K)# K943683. INVESTIGATION SUMMARY: CUSTOMER RETURNED (2) BD SAFE CLIPS (1 FROM LOT # 9120021, 1 FROM LOT # 9134024). A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9120021 AND 9134024. CUSTOMER STATES THAT THE SAFE CLIP IS JAMMED OR BLOCKED. BOTH RETURNED SAFE CLIPS WERE EXAMINED UNDER MICROSCOPE AND OBSERVED TO HAVE THE CUTTING HOLE BLOCKED WITH NEEDLES. NEEDLES WERE NOT ABLE TO BE CUT USING THE RECEIVED SAFE CLIP. 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.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. UNABLE TO PERFORM DHR CHECK FOR NOT CLIPPING/CUTTER BLOCKED AND DIFFICULT/UNABLE TO OPERATE (JAMMED) DUE TO UNKNOWN LOT NUMBER. INVESTIGATION CONCLUSION BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING USE THE NEEDLE CLIPPING DEVICE SAFE CLIP SAFECLIP WAS NOT CLIPPING/JAMMED. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES THEY "PURCHASED NEEDLE CLIPPERS, TOOK THEM OUT THE PACKAGE, THE FIRST FEW TIMES IT WORKED LIKE A CHARM. HOWEVER NOW IT'S LIKE SOMETHING IS JAMMED AND YOU CANNOT EVEN STICK A NEEDLE THROUGH THE HOLE.".

    Description of Event or Problem · 0

    IT WAS REPORTED DURING USE THE NEEDLE CLIPPING DEVICE SAFE CLIP SAFECLIP WAS NOT CLIPPING/JAMMED. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES THEY "PURCHASED NEEDLE CLIPPERS, TOOK THEM OUT THE PACKAGE, THE FIRST FEW TIMES IT WORKED LIKE A CHARM. HOWEVER NOW IT'S LIKE SOMETHING IS JAMMED AND YOU CANNOT EVEN STICK A NEEDLE THROUGH THE HOLE."

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. 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. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING USE THE NEEDLE CLIPPING DEVICE SAFE CLIP SAFECLIP WAS NOT CLIPPING/JAMMED. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES THEY "PURCHASED NEEDLE CLIPPERS, TOOK THEM OUT THE PACKAGE, THE FIRST FEW TIMES IT WORKED LIKE A CHARM. HOWEVER NOW IT'S LIKE SOMETHING IS JAMMED AND YOU CANNOT EVEN STICK A NEEDLE THROUGH THE HOLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500827 NEEDLE CLIPPING DEVICE SAFE CLIP HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other