BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PEN NDL 32G 4MM

    MDR report key: 8793700 · Received July 16, 2019

    Report

    Report Number
    9616656-2019-00629
    Event Type
    Injury
    Date Received
    July 16, 2019
    Date of Event
    June 24, 2019
    Report Date
    August 9, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403897511
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: TOMER RETURNED (1) USED 32G X 4MM BD PEN NEEDLE WITHOUT A TEAR DROP ATTACHED. IT WAS REPORTED THAT THE NEEDLE THAT PIERCES THE PEN BENT AS HE WAS ATTACHING IT. THE RETURNED SAMPLE WAS EXAMINED AND IT WAS OBSERVED THAT THE NON-PATIENT END (NPE) CANNULA WAS BROKEN; NO MANUFACTURING DEFECTS WERE OBSERVED. AS THE SAMPLE WAS RETURNED AFTER USE, AND NO MANUFACTURING DEFECTS WERE OBSERVED, THE LIKELY CAUSE OF THE BROKEN NPE CANNULA IS USER ERROR DURING ATTACHMENT OF THE PEN NEEDLE TO THE PEN INJECTOR. ATTACHING THE PEN NEEDLE OBLIQUELY TO THE PEN INJECTOR COULD RESULT IN THE BENDING OR BREAKING OF THE NPE CANNULA, WHICH WOULD LEAD TO DIFFICULTIES OPERATING THE PEN NEEDLE. 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. CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BROKEN NPE CANNULA) THE POSSIBLE ROOT CAUSE FOR THIS ISSUE IS: USER ERROR. NO EVIDENCE OF MANUFACTURING RELATED ISSUES WERE OBSERVED ON THE RETURNED SAMPLES. IT IS BD¿S EXPERIENCE THAT THE NON-PATIENT END BREAKAGE AND BENDING IS DIRECTLY ASSOCIATED WITH THE PLACING OF THE NEEDLE ONTO THE PEN DEVICE BY THE USER. IF THE NON-PATIENT END OF THE NEEDLE IS NOT PLACED CENTRALLY TO THE PEN DEVICE, THEN INSTEAD OF THE NON-PATIENT END OF THE NEEDLE PIERCING THE RUBBER SEPTUM OF THE VIAL, IT HITS HARD MATERIAL AND CAN BE BENT/BROKEN WHEN FITTED TO THE PEN.

    Description of Event or Problem · 0

    MATERIAL NO. 320122 BATCH NO. 8171673 IT WAS REPORTED THAT DURING USE OF THE BD PEN NDL 32G 4MM THE NON PATIENT END BENT WHILE ATTACHING IT TO THE INSULIN PEN. AS A RESULT THE USER DID NOT RECEIVED THE DOSE THAT HE BELIEVED HE WAS RECEIVING. THIS CAUSED HIS GLUCOSE LEVELS TO BE UNEXPECTEDLY HIGH AFTER DINNER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I NEED TO REPORT A COMPLAINT ON BEHALF OF MY PARTNER WHO USES BD NANO 4MM PEN NEEDLES. ON MONDAY, THE NEEDLE THAT PIERCES THE PEN BENT AS HE WAS ATTACHING IT. HE DID NOT REALIZE THIS HAD OCCURRED UNTIL LATER WHEN HE REMOVED THE NEEDLE. AS A RESULT, HE DID NOT RECEIVE THE DOSE THAT HE BELIEVED HE DID AND HIS GLUCOSE LEVEL WAS UNEXPECTEDLY HIGH AFTER DINNER. I HAVE ASKED HIM TO RETAIN THE SAMPLE FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO. 320122, BATCH NO. 8171673. IT WAS REPORTED THAT DURING USE OF THE BD PEN NDL 32G 4 MM THE NON PATIENT END BENT WHILE ATTACHING IT TO THE INSULIN PEN. AS A RESULT THE USER DID NOT RECEIVED THE DOSE THAT HE BELIEVED HE WAS RECEIVING. THIS CAUSED HIS GLUCOSE LEVELS TO BE UNEXPECTEDLY HIGH AFTER DINNER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I NEED TO REPORT A COMPLAINT ON BEHALF OF MY PARTNER WHO USES BD NANO 4 MM PEN NEEDLES. ON MONDAY, THE NEEDLE THAT PIERCES THE PEN BENT AS HE WAS ATTACHING IT. HE DID NOT REALIZE THIS HAD OCCURRED UNTIL LATER WHEN HE REMOVED THE NEEDLE. AS A RESULT, HE DID NOT RECEIVE THE DOSE THAT HE BELIEVED HE DID AND HIS GLUCOSE LEVEL WAS UNEXPECTEDLY HIGH AFTER DINNER. I HAVE ASKED HIM TO RETAIN THE SAMPLE FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587000 BD PEN NDL 32G 4MM HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 8171673 10885403897511

    Patients

    Seq Age Sex Outcome Treatment
    1 Other