BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ PEN NEEDLES

    MDR report key: 8805144 · Received July 18, 2019

    Report

    Report Number
    9616657-2019-00270
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Date of Event
    June 28, 2019
    Report Date
    August 9, 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
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (1) USED 32G X 4MM BD PEN NEEDLE FROM LOT 8150783. CONSUMER REPORTED WHEN SHE OPENED THE NEW BOX OF NANO NEEDLES AND ATTACHED ONE ON THE PEN TO PRIME, NOTHING CAME UP; SHE NOTICED NEEDLE IS MISSING. THE RETURNED SAMPLE WAS EXAMINED AND IT WAS OBSERVED THAT THE NON-PATIENT END (NPE) CANNULA WAS BENT, AND THE PATIENT END (PE) CANNULA WAS HOOKED. NO MANUFACTURING DEFECTS WERE OBSERVED ON THE SAMPLE. AS THE SAMPLE WAS RETURNED AFTER USE, AND NO MANUFACTURING DEFECTS WERE OBSERVED, THE LIKELY CAUSE OF THE BENT NPE CANNULA AND HOOKED PE CANNULA IS HUMAN ERROR DURING USE OF THE PEN NEEDLE. THE BENT NPE CANNULA WOULD BE THE REASON FOR NO FLOW THROUGH THE PEN NEEDLE, HENCE THE CONSUMER WOULD THINK THE PEN NEEDLE WAS 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. CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURES (HOOKED PE CANNULA, BENT NPE CANNULA) THE POSSIBLE ROOT CAUSE FOR THESE ISSUES (BENT NPE CANNULA & HOOKED 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 H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MISSING NEEDLE WAS FOUND WITH A BD ULTRA FINE¿ PEN NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CONSUMER REPORTED WHEN SHE OPENED THE NEW BOX OF NANO NEEDLES AND ATTACHED ONE ON THE PEN TO PRIME, NOTHING CAME UP TILL THE 3RD TIME. SINCE SHE IS VISUALLY IMPAIRED SHE TRIED TO TOUCH THE HUB TO FEEL TO SEE IF THERE IS A NEEDLE. SHE NOTICED NEEDLE IS MISSING. THE SECOND PEN NEEDLE WORKED. SAMPLE AVAILABLE. INCIDENT DATE-(B)(6) 2019; OCCURENCE-1; SHE BUYS HER NANO NEEDLES AT THE LOCAL PHARMACY ITEM # 320122; LOT# 8150783; EXPIRATION DATE-06-30-2023. ADVISED TO VISUALLY TEST THE NEEDLE ON BOTH END PRIOR OF USING THE NEEDLE."

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED THAT A MISSING NEEDLE WAS FOUND WITH A BD ULTRA FINE¿ PEN NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CONSUMER REPORTED WHEN SHE OPENED THE NEW BOX OF NANO NEEDLES AND ATTACHED ONE ON THE PEN TO PRIME, NOTHING CAME UP TILL THE 3RD TIME. SINCE SHE IS VISUALLY IMPAIRED SHE TRIED TO TOUCH THE HUB TO FEEL TO SEE IF THERE IS A NEEDLE. SHE NOTICED NEEDLE IS MISSING. THE SECOND PEN NEEDLE WORKED. SAMPLE AVAILABLE. INCIDENT DATE- (B)(6) 2019; OCCURENCE- 1; SHE BUYS HER NANO NEEDLES AT THE LOCAL PHARMACY ITEM # 320122; LOT# 8150783; EXPIRATION DATE- 06-30-2023. ADVISED TO VISUALLY TEST THE NEEDLE ON BOTH END PRIOR OF USING THE NEEDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599340 BD ULTRA FINE¿ PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 8150783 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other