BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 31GA 8MM

    MDR report key: 12451096 · Received September 9, 2021

    Report

    Report Number
    9616656-2021-01126
    Event Type
    Malfunction
    Date Received
    September 9, 2021
    Date of Event
    August 13, 2021
    Report Date
    September 16, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903201099
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    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: 2021-10-04. INVESTIGATION SUMMARY: CUSTOMER RETURNED A TOTAL OF 77 UNUSED 8MM, 31 GAUGE PEN NEEDLES FROM LOT 0133274. THE BROKEN NEEDLE IN QUESTION WAS NOT RETURNED. 30 OF THE SAMPLES WERE USED IN SIMULATED USE TESTING. THESE PEN NEEDLES WERE ATTACHED TO A TEST PEN AND THEN INSERTED INTO A SKIN ANALOG. ALL OF THE PEN NEEDLES WERE INTACT AFTER SIMULATED USE TESTING. ALL THE PEN NEEDLES WERE UNDAMAGED AND FUNCTIONED AS INTENDED. THE REPORTED ISSUE COULD NOT BE REPLICATED DURING TESTING. 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 PATIENT INJURY. BD WAS UNABLE TO REPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF THE NEEDLE BREAKING OFF DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD PEN NDL 31GA 8MM CANNULA BROKE OFF AND WERE TOO LONG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED THE PATIENT END OF THE NEEDLE BROKE OFF IN RIGHT SIDE OF STOMACH AND THE NEEDLE FRAGMENT WAS REMOVED USING TWEEZERS. THE CONSUMER STATED THE BELIEF THAT THE NEEDLE HIT BONE CAUSING THE PRODUCT TO BREAK OFF WITH BLEEDING A SUBSTANTIAL AMOUNT - DID NOT SEEK MEDICAL INTERVENTION AT ANY TIME. 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. 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 2 BD PEN NDL 31GA 8MM CANNULA BROKE OFF AND WERE TOO LONG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED THE PATIENT END OF THE NEEDLE BROKE OFF IN RIGHT SIDE OF STOMACH AND THE NEEDLE FRAGMENT WAS REMOVED USING TWEEZERS. THE CONSUMER STATED THE BELIEF THAT THE NEEDLE HIT BONE CAUSING THE PRODUCT TO BREAK OFF WITH BLEEDING A SUBSTANTIAL AMOUNT - DID NOT SEEK MEDICAL INTERVENTION AT ANY TIME. DATE OF EVENT : UNKNOWN. SAMPLES : AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1348340 PEN NDL 31GA 8MM HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320109 0133274 00382903201099

    Patients

    Seq Age Sex Outcome Treatment
    1