BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 31GA 5MM 14BAG 700CAS JP

    MDR report key: 11548213 · Received March 22, 2021

    Report

    Report Number
    9616656-2021-00302
    Event Type
    Malfunction
    Date Received
    March 22, 2021
    Date of Event
    February 24, 2021
    Report Date
    April 23, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    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: 2021-04-22. H6: INVESTIGATION SUMMARY: ONE OPEN 31G X 5MM PEN NEEDLE SAMPLE AND THREE PHOTOS WERE RETURNED FROM LOT. NO. 0203811, CAT. NO.320129. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLE AND PHOTOS AND DAMAGE TO THE HUB WAS 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. THIS ISSUE MOST LIKELY OCCURRED DUE TO A JAM ON THE MACHINE DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PEN NDL 31GA 5MM 14BAG 700CAS JP WAS FOUND TO BE DAMAGED AND WAS DIFFICULT TO OPERATE DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE CUSTOMER REPORTED AS FOLLOWS: THE PLASTIC COMPONENT (HUB) WAS DEFORMED AND THE PEN NEEDLE WAS NOT ATTACHED TO THE PEN. (B)(6) 2021/3/4 LOT NUMBER IS UPDATED FROM UNKNOWN TO 0203811."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 WAS FOUND TO BE DAMAGED AND WAS DIFFICULT TO OPERATE DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE CUSTOMER REPORTED AS FOLLOWS: THE PLASTIC COMPONENT (HUB) WAS DEFORMED AND THE PEN NEEDLE WAS NOT ATTACHED TO THE PEN. (B)(6), (B)(6) 2021. LOT NUMBER IS UPDATED FROM UNKNOWN TO 0203811."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444884 PEN NDL 31GA 5MM 14BAG 700CAS JP HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 0203811

    Patients

    Seq Age Sex Outcome Treatment
    1