BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE PEN NEEDLES

    MDR report key: 11837680 · Received May 17, 2021

    Report

    Report Number
    9616656-2021-00543
    Event Type
    Malfunction
    Date Received
    May 17, 2021
    Date of Event
    April 20, 2021
    Report Date
    June 10, 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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-05-24. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED 19 PEN NEEDLES. THESE PEN NEEDLES ARE ALL 4MM, 32 GAUGE PEN NEEDLES. THEIR TEARDROP LABELS SHOW THAT THEY ARE FROM LOTS 0133297 AND 0142932. EACH OF THESE PEN NEEDLES WAS ATTACHED TO A TEST PEN FILLED WITH SALINE. THE PEN WAS PRIMED AND SALINE WAS PUSHED THROUGH THE SYSTEM. THE SALINE PASSED THROUGH THE SYSTEM AND EXITED THE DISTAL TIP OF THE CANNULA WITHOUT ISSUE. NONE OF THE PEN NEEDLES WERE FOUND TO BE CLOGGED. NO OTHER DEFECTS OR DAMAGE WERE OBSERVED. 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 WAS NOT ABLE TO REPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF THE PEN NEEDLES BEING CLOGGED. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD ULTRA FINE¿ PEN NEEDLE 4MM X 32G WAS UNABLE TO DELIVER INSULIN/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : MATERIAL NO. 320550 BATCH NO. 0133297. IT WAS REPORTED THAT THERE IS NO INSULIN FLOW DURING INJECTION. CONSUMER STATED, 4 OUT OF 5 PEN NEEDLES DO NOT WORK. 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. THE CUSTOMER'S ALTERNATIVE TELEPHONE NUMBER ADDITIONALLY REPORTED : (B)(6). A DEVICE EVALUATION IS PENDING 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 1 BD ULTRA FINE¿ PEN NEEDLE 4MM X 32G WAS UNABLE TO DELIVER INSULIN/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : MATERIAL NO. 320550, BATCH NO. 0133297. IT WAS REPORTED THAT THERE IS NO INSULIN FLOW DURING INJECTION. CONSUMER STATED, 4 OUT OF 5 PEN NEEDLES DO NOT WORK DATE OF EVENT: UNKNOWN. SAMPLES: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732409 BD ULTRA FINE PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 0133297 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1