BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFE-CLIP¿ NEEDLE CLIPPING & STORAGE DEVICE

    MDR report key: 9117131 · Received September 25, 2019

    Report

    Report Number
    2243072-2019-02113
    Event Type
    Malfunction
    Date Received
    September 25, 2019
    Date of Event
    September 10, 2019
    Report Date
    October 2, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    K943683
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D.1. MEDICAL DEVICE BRAND NAME: BD SAFE-CLIP¿ NEEDLE CLIPPING & STORAGE DEVICE. D.2. COMMON DEVICE NAME: HYPODERMIC SINGLE LUMEN NEEDLE. THE MANUFACTURING LOCATION FOR THIS PRODUCT IS NYPRO, MX. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1., AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. D.2. MEDICAL DEVICE CATALOG #: 328235. D.4. MEDICAL DEVICE EXPIRATION DATE: N/A. D.4. MEDICAL DEVICE LOT #: 1334211. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). D.10. DEVICE AVAILABLE FOR EVAL? YES. D.10. RETURNED TO MANUFACTURER ON: 2019-09-25. G.5. PMA/510(K)#: K943683. H.3. DEVICE RETURNED TO MANUFACTURER: YES. H.4. DEVICE MANUFACTURE DATE: 2012-01-12.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED ONE (1) USED BD SAFE-CLIP DEVICE FROM LOT 1334211. CONSUMER REPORTED BD SAFECLIP IS CLOGGED, NOT ABLE TO PUT NEEDLE IN HOLE, STATED, IT¿S BLOCKED/CLOGGED. THE RETURNED SAFE-CLIP DEVICE WAS EXAMINED, AND NO APPARENT DEFECTS WERE OBSERVED. THE SAFE-CLIP WAS THEN USED TO CLIP THREE TEST CANNULA: THE THREE CANNULA WERE ABLE TO BE INSERTED INTO THE SAFE-CLIP CUTTING HOLE, AND THE SAFE-CLIP WAS ABLE TO CLIP ALL THREE PROPERLY. AS NO MANUFACTURING DEFECTS WERE OBSERVED, THE ALLEGED ISSUE COULD NOT BE CONFIRMED. ACCORDING WITH THE DHR REVIEW INFORMATION, THE PROBLEM ¿CUTTER BLOCKED¿ HAS NO NHB ASSEMBLY PROCESS RELATION, ALL SAMPLES OF SAFE CLIP DISPOSABLE CUTTER (USA) PASSED FUNCTIONAL TEST (SAMPLE PLAN C=0 AND AQL=1). BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. H3 OTHER TEXT : SEE SECTION H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SAFE-CLIP¿ NEEDLE CLIPPING & STORAGE DEVICE IS CLOGGED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN; BATCH NO: UNKNOWN. IT WAS REPORTED THAT THE BD SAFECLIP IS CLOGGED, NOT ABLE TO PUT NEEDLE IN HOLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SAFE-CLIP¿ NEEDLE CLIPPING & STORAGE DEVICE IS CLOGGED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN . BATCH NO: UNKNOWN. IT WAS REPORTED THAT THE BD SAFECLIP IS CLOGGED, NOT ABLE TO PUT NEEDLE IN HOLE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNSPECIFIED BD¿ SAFECLIP IS CLOGGED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN. IT WAS REPORTED THAT THE BD SAFECLIP IS CLOGGED, NOT ABLE TO PUT NEEDLE IN HOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915217 BD SAFE-CLIP¿ NEEDLE CLIPPING & STORAGE DEVICE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 1334211

    Patients

    Seq Age Sex Outcome Treatment
    1 Other