BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE 31GX5MM

    MDR report key: 10544418 · Received September 16, 2020

    Report

    Report Number
    3006948883-2020-00415
    Event Type
    Malfunction
    Date Received
    September 16, 2020
    Date of Event
    September 4, 2020
    Report Date
    September 10, 2020
    Manufacturer
    BD (SUZHOU)
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: A REVIEW OF RISK MANAGEMENT DOCUMENT (B)(4), INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (PEN NEEDLE: NEEDLE CLOG) WAS CAPTURED AND ADDRESSED. LOT#0041562 DHR WAS REVIEWED AND NO QN FOUND; MANUFACTURE RECORDS WERE REVIEWED, NO ABNORMAL WAS FOUND. PEN NEEDLE PRODUCT HAS 100% CLOG TEST IN FLOWGURU STATION, AND DEFECT PART WILL BE REJECTED BY FLOWGURU STATION AUTOMATICALLY. CLOG AND NP GAP TEST WAS CONDUCTED ON 7PCS RETENTION SAMPLES AND ALL NO NEEDLE CLOG OR NP GAP FAIL FOUND. BASE ON INVESTIGATION ABOVE, THE CERTAIN CAUSE CANNOT BE CONCLUDED AT THE MOMENT. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION ABOVE, THE CERTAIN CAUSE CANNOT BE CONCLUDED AT THE MOMENT. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. HOWEVER, WE WILL KEEP MONITOR ON SIMILAR ISSUE FROM FILED AND TRENDING REGULARLY. ROOT CAUSE DESCRIPTION: LOT#0041562 DHR AND RELATED MANUFACTURING RECORDS WERE REVIEWED, NO ABNORMALITY WAS FOUND. PEN NEEDLE PRODUCT HAS 100% CLOG TEST IN FLOWGURU STATION, AND DEFECT PART WILL REJECTED BY FLOWGURU STATION AUTOMATICALLY. CLOG AND NP GAP TEST WAS CONDUCTED ON 7 PCS RETENTION SAMPLES AND ALL NO NEEDLE CLOG OR NP GAP FAIL FOUND. BASED ON THE INVESTIGATION ABOVE, THE CERTAIN CAUSE CANNOT BE CONCLUDED AT THE MOMENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING PEN NEEDLES 31 G X 5 MM MEDICATION DID NOT FLOW FROM 5 NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER BOUGHT A BOX OF 98 PEN NEEDLES FROM PHARMACY AND CUSTOMER HAD USED 2 PACKS, 14 NEEDLES IN A PACK, AND 5 NEEDLES IN THE TWO PACKS DIDN'T FLOW DRUG. CUSTOMER HOPED THE NEEDLE'S QUALITY COULD BE IMPROVED, AND NEEDED CLAIM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009070 PEN NEEDLE 31GX5MM PEN NEEDLE FMI BD (SUZHOU) 0041562

    Patients

    Seq Age Sex Outcome Treatment
    1 Other