BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ ULTRA-FINE¿ PEN NEEDLE

    MDR report key: 12929630 · Received December 3, 2021

    Report

    Report Number
    8041187-2021-01020
    Event Type
    Malfunction
    Date Received
    December 3, 2021
    Date of Event
    November 6, 2021
    Report Date
    January 20, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    10885403897511
    PMA / PMN Number
    K131358
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. INITIAL REPORTER STATE: ADDRESS INFORMATION WAS NOT ABLE TO BE OBTAINED, THEREFORE, (B)(6)WAS USED AS A PLACE HOLDER. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL: YES. D10: RETURNED TO MANUFACTURER ON: 2021-12-31. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (10) 32GX4MM BD PEN NEEDLES WITHOUT TEAR DROP LABELS ATTACHED. THE CONSUMER REPORTED 10 DEFECTIVE NEEDLES: 9 PEN NEEDLES WOULD NOT RELEASE INSULIN, 1 PEN NEEDLE HAD A NEEDLE BENT OVER UNDER THE GREEN CAP AFTER OPENING. ALL 10 RETURNED PEN NEEDLES WERE EXAMINED, AND THE FOLLOWING WAS OBSERVED: 7 EXHIBITED A BENT NON-PATIENT END (NPE) CANNULA - 1 EXHIBITED A BROKEN NPE CANNULA NONE OF THE RETURNED SAMPLES EXHIBITED A BENT PATIENT END (PE) CANNULA. 2 SAMPLES WITH STRAIGHT NPE CANNULAS WERE TESTED FOR FLOW USING A TEST PEN INJECTOR, AND BOTH WERE ABLE TO EXPEL PROPERLY. THE BENT AND BROKEN NON-PATIENT END (NPE) CANNULAS WOULD BE THE CAUSE FOR ANY DIFFICULTY WHEN USING THE PEN NEEDLES, HENCE, THE CUSTOMER WOULD THINK THE PEN NEEDLES WERE DEFECTIVE OR CLOGGED. SINCE THE SAMPLES WERE RETURNED AFTER USE, THE PROBABLE CAUSE OF THE BENT AND BROKEN NPE CANNULAS IS USER RELATED. PEN NEEDLE DHR BATCH 0160115 WAS REVIEWED: THE BATCH NUMBER WAS BUILT WITH PEN NEEDLE ASSEMBLY LINE IN (B)(6) 2020. REVIEW OF THE DHR REVEALED ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. NO QUALITY NOTIFICATION WAS RAISED ON PAST 12 MONTHS ON SIMILAR NON-CONFORMANCE. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (NPE CANNULA BENT NPE CANNULA BROKEN) THE ROOT CAUSE FOR THIS ISSUE IS USER RELATED. THE NPE CANNULAS WERE BENT OR BROKEN AFTER THE USER HANDLED THE PEN NEEDLES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD NANO¿ ULTRA-FINE¿ PEN NEEDLE WAS DIFFICULT TO OPERATE AND THERE WERE 9 NEEDLES THAT WERE UNABLE TO DELIVER MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2021, USED BD NANO ULTRA-FINE PEN NEEDLES AND HAVE HAD 10 DEFECTIVE NEEDLES IN THIS SUPPLY LOT #0160115 EXP: 7-31-2025.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD NANO¿ ULTRA-FINE¿ PEN NEEDLE WAS DIFFICULT TO OPERATE AND THERE WERE 9 NEEDLES THAT WERE UNABLE TO DELIVER MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) 2021: USED BD NANO ULTRA-FINE PEN NEEDLES AND HAVE HAD 10 DEFECTIVE NEEDLES IN THIS SUPPLY LOT #0160115; EXP: 7-31-2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1822682 BD NANO¿ ULTRA-FINE¿ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 8975 0160115 10885403897511

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown