BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 31G 5MM 100CT GR NO PT ROCHE

    MDR report key: 8440383 · Received March 21, 2019

    Report

    Report Number
    9616656-2019-00268
    Event Type
    Malfunction
    Date Received
    March 21, 2019
    Date of Event
    March 4, 2019
    Report Date
    May 3, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    NSC
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: TWENTY TWO SEALED 31G X 5MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 7241731, CAT. NO. 320677. VISUAL EXAMINATION AND A FUNCTIONALITY TEST WAS CARRIED OUT ON ALL TWENTY TWO SAMPLES AND NO ISSUES 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 PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. NO ISSUES WERE OBSERVED WITH THE RETURNED SAMPLES THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PEN NDL 31G 5MM 100CT GR NO PT ROCHE HAD NEEDLE GUARDS THAT FELL OFF. THE FOLLOWING WAS REPORTED, "NEEDLE GUARD IS NOT CORRECTLY CONNECTED WITH FEW NEEDLES FROM THIS BOX. CUSTOMER MEANED THE NEEDLE GUARD IS TOO BIG BECAUSE THE NEEDLE GUARD DROPPED OFF IN PACKAGE. CUSTOMER HAS BEEN INJURED ACCIDENTALLY. NO HEALTH EVENTS." NO MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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 A PEN NDL 31G 5MM 100CT GR NO PT ROCHE HAD NEEDLE GUARDS THAT FELL OFF. THE FOLLOWING WAS REPORTED, "NEEDLE GUARD IS NOT CORRECTLY CONNECTED WITH FEW NEEDLES FROM THIS BOX. CUSTOMER MEANED THE NEEDLE GUARD IS TOO BIG BECAUSE THE NEEDLE GUARD DROPPED OFF IN PACKAGE. CUSTOMER HAS BEEN INJURED ACCIDENTALLY. NO HEALTH EVENTS." NO MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235287 PEN NDL 31G 5MM 100CT GR NO PT ROCHE PEN NEEDLE NSC BECTON DICKINSON AND CO. 7241731

    Patients

    Seq Age Sex Outcome Treatment
    1 Other