BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE PEN NEEDLES 32G 4MM

    MDR report key: 11823731 · Received May 13, 2021

    Report

    Report Number
    9616656-2021-00524
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    April 15, 2021
    Report Date
    June 7, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K182320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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: 2021-04-30. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (5) OPEN 4MM, 32G PEN NEEDLES WITHOUT THE TEAR DROP LABEL OR INNER SHIELD. CUSTOMER STATES THAT THE NEEDLE CLOGGED DURING INJECTION. ALL RETURNED PEN NEEDLES WERE EXAMINED AND 4 OUT OF 5 SAMPLES EXHIBITED A BENT NON PATIENT END OF THE CANNULA. THE REMAINING SAMPLE EXHIBITED A BROKEN NON PATIENT END OF THE CANNULA. 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 CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE IS USER RELATED. THE BENT AND BROKEN NON PATIENT END OF THE CANNULA OCCURRED DURING USE OF THE PRODUCT BY THE CUSTOMER. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD ULTRA FINE¿ PEN NEEDLE 32G 4MM WAS UNABLE TO DELIVER INSULIN/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : MATERIAL NO. 320550, BATCH NO. 0203822. CONSUMER REPORTED THE NEEDLE CLOG DURING INJECTION, STATED THAT THERE IS NO INSULIN FLOW. LOT #: 0203822. CATALOG #: 320550. DATE OF EVENT: UNKNOWN. SAMPLES: AVAILABLE - SENDING MAIL KIT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 32G 4MM WAS UNABLE TO DELIVER INSULIN/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320550. BATCH NO. 0203822. CONSUMER REPORTED THE NEEDLE CLOG DURING INJECTION, STATED THAT THERE IS NO INSULIN FLOW. LOT #: 0203822. CATALOG #: 320550. DATE OF EVENT: UNKNOWN. SAMPLES: AVAILABLE - SENDING MAIL KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712762 BD ULTRA FINE PEN NEEDLES 32G 4MM HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 0203822 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1