BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO 100 BOX 1200 US

    MDR report key: 12256737 · Received July 30, 2021

    Report

    Report Number
    1920898-2021-00838
    Event Type
    Malfunction
    Date Received
    July 30, 2021
    Date of Event
    July 2, 2021
    Report Date
    August 24, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    PMA / PMN Number
    K182320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D2: MEDICAL DEVICE BRAND NAME: PEN NDL 32G 4MM PRO 100 BOX 1200 US; D2: COMMON DEVICE NAME: HYPODERMIC SINGLE LUMEN NEEDLE; D4: MODEL # 320550; D4: MEDICAL DEVICE LOT #: 0330602; D4: MEDICAL DEVICE EXPIRATION DATE: 2025-11-30; D4: UDI # (B)(4); G.5. PMA / 510(K)#: K182320; H4: DEVICE MANUFACTURE DATE: 2020-11-25. D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-08-23. H6: INVESTIGATION SUMMARY CUSTOMER RETURNED A SINGLE UNOPENED 4MM, 32 GAUGE NANO PRO PEN NEEDLE FROM LOT 0330602. THE PEN NEEDLE WAS ATTACHED TO A TEST PEN, PRIMED, AND SALINE WAS PUSHED THROUGH THE SYSTEM. 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 UNABLE TO REPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF DIFFICULTY OPERATING THE PEN NEEDLE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 UNSPECIFIED BD SYRINGE 3ML HAD LEAKAGE AND A DOSAGE ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED INSULIN IS LEAKING OUT OF THE INJECTION SITE OR FROM THE PATIENT END NEEDLE AFTER INJECTION. DATE OF EVENT : UNKNOWN; SAMPLES : AVAILABLE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE : UNKNOWN. A DEVICE EVALUATION IS PENDING BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE : UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 1 UNSPECIFIED BD SYRINGE 3ML HAD LEAKAGE AND A DOSAGE ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED INSULIN IS LEAKING OUT OF THE INJECTION SITE OR FROM THE PATIENT END NEEDLE AFTER INJECTION. DATE OF EVENT : UNKNOWN. SAMPLES : AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1149420 PEN NDL 32G 4MM PRO 100 BOX 1200 US HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL - DIABETES CARE 0330602

    Patients

    Seq Age Sex Outcome Treatment
    1