BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10164888 · Received June 17, 2020

    Report

    Report Number
    9616656-2020-00557
    Event Type
    Malfunction
    Date Received
    June 17, 2020
    Date of Event
    May 28, 2020
    Report Date
    June 18, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903201228
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY CUSTOMER RETURNED ONE (1) USED 32GX4MM BD PEN NEEDLE FROM LOT 8150784. CONSUMER REPORTED THAT THE PEN NEEDLE IS TOO SHORT, AND DUE TO THAT THE INSULIN IS NOT FLOWING. THE RETURNED PEN NEEDLE WAS EXAMINED, AND IT WAS OBSERVED THAT THE NON-PATIENT END (NPE) CANNULA WAS BROKEN. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED. THE BROKEN NPE CANNULA WOULD BE THE REASON FOR NO FLOW THROUGH THE PEN NEEDLE, HENCE, THE CUSTOMER WOULD THINK THE NPE CANNULA WAS TOO SHORT AND THE PEN NEEDLE CLOGGED (AS REPORTED). SINCE THE PEN NEEDLE WAS RETURNED AFTER USE, AND NO MANUFACTURING DEFECTS WERE OBSERVED, THE PROBABLE CAUSE OF THE BROKEN NPE CANNULA IS USER ERROR WHEN ATTACHING THE PEN NEEDLE TO A PEN INJECTOR. 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 AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BROKEN NPE CANNULA) USER ERROR. NO EVIDENCE OF MANUFACTURING RELATED ISSUES WERE OBSERVED ON THE RETURNED SAMPLES. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G EXPERIENCED PRODUCT DAMAGE WHILE STILL CONSIDERED OPERABLE, AND WAS UNABLE OR DIFFICULT TO PRIME. PRODUCT DEFECTS WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320122 BATCH NO:8150784 VERBATIM: CONSUMER REPORTED WHEN ATTACHING HIS PEN NEEDLE TO HIS FLEX PEN THE NEEDLE IS TO SHORT INSIDE OF THE HOUSING PART (HUB). STATED THAT DUE TO THE NEEDLE BEING TO SHORT, THERE IS NO INSULIN FLOW DURING HIS PRIMING. DATE OF EVENT: UNKNOWN.

    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.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G EXPERIENCED PRODUCT DAMAGE WHILE STILL CONSIDERED OPERABLE, AND WAS UNABLE OR DIFFICULT TO PRIME. PRODUCT DEFECTS WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320122 BATCH NO:8150784. VERBATIM: CONSUMER REPORTED WHEN ATTACHING HIS PEN NEEDLE TO HIS FLEX PEN THE NEEDLE IS TO SHORT INSIDE OF THE HOUSING PART (HUB). STATED THAT DUE TO THE NEEDLE BEING TO SHORT, THERE IS NO INSULIN FLOW DURING HIS PRIMING. DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629879 BD ULTRA-FINE NANO PEN NEEDLES 4MM (5/32) 32G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320122 8150784 00382903201228

    Patients

    Seq Age Sex Outcome Treatment
    1 Other