BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G

    MDR report key: 8778320 · Received July 10, 2019

    Report

    Report Number
    9616657-2019-00256
    Event Type
    Malfunction
    Date Received
    July 10, 2019
    Date of Event
    June 20, 2019
    Report Date
    July 18, 2019
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403928659
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED (8) USED 32G X 4MM BD PEN NEEDLES WITHOUT TEAR DROP LABELS ATTACHED. CONSUMER REPORTED FINDING CLOGS DURING INJECTION WITH SOLO STAR PEN FINDING THE NON PATIENT END TO BE BENT. ALL 8 RETURNED SAMPLES WERE EXAMINED AND THE FOLLOWING WAS OBSERVED: -6 SAMPLES WITH BENT NON-PATIENT END (NPE) CANNULAS; 3 OF THESE SAMPLES WERE ALSO BENT ON THE PATIENT END (PE) CANNULA -1 SAMPLE WITH A BROKEN NPE CANNULA. -1 SAMPLE WITH A GOOD NPE CANNULA; THIS SAMPLE WAS TESTED FOR FLOW USING A TEST PEN INJECTOR AND PASSED. AS ALL 8 SAMPLES WERE RETURNED AFTER USE, AND NO MANUFACTURING DEFECTS WERE OBSERVED, THE LIKELY CAUSE OF THE BENT OR BROKEN NPE CANNULAS IS USER ERROR DURING PEN NEEDLE ATTACHMENT TO A PEN INJECTOR. THE LIKELY CAUSE OF THE BENT PE CANNULAS IS ALSO HUMAN ERROR DURING USE OF THE PEN NEEDLES. THE BENT OR BROKEN PE OR NPE CANNULAS WOULD BE THE REASON FOR NO FLOW THROUGH THE PEN NEEDLES, HENCE THE CONSUMER WOULD THINK THE PEN NEEDLES WERE CLOGGED (AS REPORTED). A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: -CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURES (BENT NPE CANNULA, BROKEN NPE CANNULA, BENT PE CANNULA). 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. THE POSSIBLE ROOT CAUSE FOR THESE ISSUES (BENT NPE CANNULA, BROKEN NPE CANNULA, BENT PE CANNULA) IS: USER ERROR. NO EVIDENCE OF MANUFACTURING RELATED ISSUES WERE OBSERVED ON THE RETURNED SAMPLES. IT IS BD¿S EXPERIENCE THAT THE NON-PATIENT END BREAKAGE AND BENDING IS DIRECTLY ASSOCIATED WITH THE PLACING OF THE NEEDLE ONTO THE PEN DEVICE BY THE USER. IF THE NON-PATIENT END OF THE NEEDLE IS NOT PLACED CENTRALLY TO THE PEN DEVICE, THEN INSTEAD OF THE NON-PATIENT END OF THE NEEDLE PIERCING THE RUBBER SEPTUM OF THE VIAL, IT HITS HARD MATERIAL AND CAN BE BENT/BROKEN WHEN FITTED TO THE PEN. H3 OTHER TEXT : SEE SECTION H.10

    Description of Event or Problem · 0

    MATERIAL NO.: 320122. BATCH NO.: 8066608. IT WAS REPORTED THAT DURING USE OF THE BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G THE NEEDLES CLOGS DURING INJECTION AND CONSUMER ALSO REPORTED THE CANNULA WAS BENT ON THE NON PATIENT END. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ITEM # 320122 LOT # 8066608 FINDING CLOGS DURING INJECTION WITH SOLO STAR PEN FINDING THE NON PATIENT END TO BE BENT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO.: 320122, BATCH NO.: 8066608. IT WAS REPORTED THAT DURING USE OF THE BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G THE NEEDLES CLOGS DURING INJECTION AND CONSUMER ALSO REPORTED THE CANNULA WAS BENT ON THE NON PATIENT END. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ITEM # 320122 LOT # 8066608 FINDING CLOGS DURING INJECTION WITH SOLO STAR PEN FINDING THE NON PATIENT END TO BE BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572598 BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON AND CO. 8066608 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other