BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEN NDL 31GA 5MM 14BAG 700CAS JP

    MDR report key: 11536720 · Received March 20, 2021

    Report

    Report Number
    9616656-2021-00300
    Event Type
    Injury
    Date Received
    March 20, 2021
    Date of Event
    February 22, 2021
    Report Date
    April 23, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: H6: INVESTIGATION SUMMARY: TWENTY SIX SEALED 31G X 5MM PEN NEEDLE SAMPLES AND TWO PHOTOS WERE RETURNED FROM LOT. NO. 9226278, CAT. NO. 321029. VISUAL EXAMINATION AND A FUNCTIONALITY TEST WAS CARRIED OUT ON ALL TWENTY SIX 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 AS 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 31GA 5MM 14BAG 700CAS JP HAD THE OUTER SHIELD UNABLE TO DETATCH LEADING TO A NEEDLE STICK DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "ACCORDING TO THE PATIENT'S REPORT, WHEN DETACHING THE PEN NEEDLE FROM THE PEN, THE NEEDLE NPE WAS SEPARATED FROM THE HUB/OUTER COVER. THE PATIENT'S SON PRICKED HIS FINGER ON THE NEEDLE. THE SITUATION REMAINS UNKNOWN."

    Additional Manufacturer Narrative · 1

    "A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. "

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PEN NDL 31GA 5MM 14BAG 700CAS JP HAD THE OUTER SHIELD UNABLE TO DETATCH LEADING TO A NEEDLE STICK DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "ACCORDING TO THE PATIENT'S REPORT, WHEN DETACHING THE PEN NEEDLE FROM THE PEN, THE NEEDLE NPE WAS SEPARATED FROM THE HUB/OUTER COVER. THE PATIENT'S SON PRICKED HIS FINGER ON THE NEEDLE. THE SITUATION REMAINS UNKNOWN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431710 PEN NDL 31GA 5MM 14BAG 700CAS JP HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 9226278

    Patients

    Seq Age Sex Outcome Treatment
    1 Other