BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO

    MDR report key: 12333648 · Received August 17, 2021

    Report

    Report Number
    9616656-2021-01011
    Event Type
    Malfunction
    Date Received
    August 17, 2021
    Date of Event
    July 19, 2021
    Report Date
    September 28, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: ADDITIONAL LOT NUMBER RECEIVED. D4: MEDICAL DEVICE LOT #: 1012829. D4: MEDICAL DEVICE EXPIRATION DATE: 2026-01-31. H4: DEVICE MANUFACTURE DATE: 2021-01-12. D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-09-28. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED A TOTAL OF 11 PEN NEEDLES. ALL WERE OPENED 4MM, 32 GAUGE NANO PROS WITH 7 FROM LOT 1006150 AND 4 FROM LOT 1012829. THE PEN NEEDLES WERE VISUALLY INSPECTED PRIOR TO TESTING. 8 OF THE PEN NEEDLES WERE FOUND TO HAVE BROKEN NEEDLES ON THE NON-PATIENT SIDE OF THE HUB¿S NEEDLE CANNULA. ADDITIONALLY, 2 WERE BENT ON THE SAME SIDE. THIS DAMAGE WOULD PREVENT TESTING FOR CLOGS SINCE THE NEEDLE CANNOT PROPERLY ATTACH TO THE PEN. AS A RESULT, THE PEN NEEDLES APPEAR TO BE CLOGGED DURING USE. BASED ON THE DAMAGE PRESENT, THE NEEDLES BENDING OR BREAKING MAY HAVE OCCURRED ACCIDENTALLY WHILE THE USER WAS PREPARING THE PEN NEEDLE FOR USE, POTENTIALLY IF THE PEN WAS NOT PROPERLY ALIGNED WITH THE CANNULA. THE REMAINING SAMPLE WAS ATTACHED TO A TEST PEN FILLED WITH SALINE. SALINE WAS PUSHED THROUGH THE SYSTEM AND OUT THE DISTAL TIP OF THE REMAINING PEN NEEDLE. NO ISSUES WERE FOUND WITH THE REMAINING PEN NEEDLE. 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. BASED ON THE SAMPLES RECEIVED, BD FOUND THAT 8 PEN NEEDLES HAD BECOME BROKEN AND 2 HAD BEEN BENT ON THE NON-PATIENT SIDE. THIS DAMAGE COULD RESEMBLE THE NEEDLE BEING CLOGGED AS A RESULT OF INSULIN NOT PASSING THROUGH THE NEEDLE. THE ROOT CAUSE OF THE NEEDLES BENDING AND BREAKING APPEARS TO BE ACCIDENTAL DAMAGE FROM STRESSES CAUSED BY THE USER DURING ROUTINE USE. THIS WOULD HAVE ALSO GIVEN THE IMPRESSION.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD PEN NDL 32G 4MM PRO WERE UNABLE TO PRIME AND UNABLE TO DELIVER INSULIN OR MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SPOUSE OF CONSUMER STATED THAT THERE WAS NO INSULIN FLOW WHEN PRIMING AND NO INSULIN FLOW WHEN TAKING THE INJECTION. DATE OF EVENT: UNKNOWN. SAMPLES: YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD PEN NDL 32G 4MM PRO WERE UNABLE TO PRIME AND UNABLE TO DELIVER INSULIN OR MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE SPOUSE OF CONSUMER STATED THAT THERE WAS NO INSULIN FLOW WHEN PRIMING AND NO INSULIN FLOW WHEN TAKING THE INJECTION. DATE OF EVENT : UNKNOWN SAMPLES : YES.

    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

    IT WAS REPORTED THAT 2 BD PEN NDL 32G 4MM PRO WERE UNABLE TO PRIME AND UNABLE TO DELIVER INSULIN OR MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE SPOUSE OF CONSUMER STATED THAT THERE WAS NO INSULIN FLOW WHEN PRIMING AND NO INSULIN FLOW WHEN TAKING THE INJECTION. DATE OF EVENT : UNKNOWN. SAMPLES : YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229705 PEN NDL 32G 4MM PRO HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 SEE H10 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1