BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEN NDL 32G 4MM HP 100 BOX 1200 US

    MDR report key: 10978866 · Received December 9, 2020

    Report

    Report Number
    9616656-2020-01246
    Event Type
    Injury
    Date Received
    December 9, 2020
    Date of Event
    November 15, 2020
    Report Date
    January 19, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K182320
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 12/4/2020. H.6. INVESTIGATION: CUSTOMER RETURNED THREE (3) USED 32GX4MM BD PEN NEEDLES WITHOUT TEAR DROP LABELS OR INNER SHIELDS ATTACHED. CONSUMER REPORTED NEEDLE CLOG DURING INJECTION. ALL 3 RETURNED PEN NEEDLES WERE EXAMINED, AND IT WAS OBSERVED THAT ALL 3 EXHIBITED A BENT NON-PATIENT END (NPE) CANNULA. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED. THE BENT NPE CANNULAS WOULD BE THE CAUSE FOR NO FLOW THROUGH THE PEN NEEDLES, HENCE, THE CUSTOMER WOULD THINK THE PEN NEEDLES WERE CLOGGED (AS REPORTED). SINCE ALL 3 PEN NEEDLES WERE RETURNED AFTER USE, AND NO MANUFACTURING DEFECTS WERE OBSERVED, THE PROBABLE CAUSE OF THE BENT NPE CANNULAS IS USER ERROR WHEN ATTACHING THE PEN NEEDLES TO A PEN INJECTOR. 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. 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

    IT WAS REPORTED THAT A PEN NDL 32G 4MM HP 100 BOX 1200 US WAS UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REOPRTER: "IT WAS REPORTED THAT THE NEEDLE CLOGGED DURING THE INJECTION AND THE CONSUMER'S GLUCOSE LEVEL WAS ELEVATED. VERBATIM: CONSUMER REPORTED NEEDLE CLOG DURING INJECTION, STATED THAT SHE DOES NOT ALWAYS PRIME NEEDLES. ALSO MENTIONED THAT HER GLUCOSE LEVEL WAS ELEVATED THIS MORNING."

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PEN NDL 32G 4MM HP 100 BOX 1200 US WAS UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE NEEDLE CLOGGED DURING THE INJECTION AND THE CONSUMER'S GLUCOSE LEVEL WAS ELEVATED. (B)(4): CONSUMER REPORTED NEEDLE CLOG DURING INJECTION, STATED THAT SHE DOES NOT ALWAYS PRIME NEEDLES. ALSO MENTIONED THAT HER GLUCOSE LEVEL WAS ELEVATED THIS MORNING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1442849 PEN NDL 32G 4MM HP 100 BOX 1200 US HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 9184145 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Other