BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEN NDL 32G 4MM 100BX 1200 USA

    MDR report key: 10939147 · Received December 3, 2020

    Report

    Report Number
    9616657-2020-00171
    Event Type
    Injury
    Date Received
    December 3, 2020
    Date of Event
    November 9, 2020
    Report Date
    January 20, 2021
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903201228
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 TWO (2) USED 32GX4MM BD PEN NEEDLES FROM LOT: 9294863. CONSUMER REPORTED FOUND 2 PEN NEEDLES THAT CLOG DURING INJECTION. BOTH RETURNED PEN NEEDLES WERE EXAMINED, AND IT WAS OBSERVED THAT 1 PEN NEEDLE HAD A BROKEN NON-PATIENT END (NPE) CANNULA (SEE ATTACHED PHOTO), AND 1 PEN NEEDLE HAD A STRAIGHT NPE CANNULA. THE PEN NEEDLE WITH THE STRAIGHT NPE CANNULA WAS TESTED FOR FLOW USING A TEST PEN INJECTOR: THIS PEN NEEDLE WAS ABLE TO EXPEL PROPERLY. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED. THE BROKEN NPE CANNULA WOULD BE THE CAUSE FOR NO FLOW THROUGH THE PEN NEEDLE, HENCE, THE CUSTOMER WOULD THINK THE PEN NEEDLE WAS CLOGGED (AS REPORTED). SINCE BOTH PEN NEEDLES WERE RETURNED AFTER USE, AND NO MANUFACTURING DEFECTS WERE OBSERVED, THE PROBABLE CAUSE OF THE BROKEN NPE CANNULA 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 PEN NDL 32G 4MM 100BX 1200 USA WAS CLOGGED ON 2 OCCASIONS AND THE GLUCOSE LEVEL WAS HIGH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:320122, BATCH NO: 9294863. IT WAS REPORTED THAT THE PARENT OF A MINOR CONSUMER FOUND TWO PEN NEEDLES TO CLOG DURING THE INJECTION. ALSO, REPORTED THE GLUCOSE LEVEL TO BE A LITTLE ON THE HIGH SIDE.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED PEN NDL 32G 4MM 100BX 1200 USA WAS CLOGGED ON 2 OCCASIONS AND THE GLUCOSE LEVEL WAS HIGH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320122 ; BATCH NO: 9294863. IT WAS REPORTED THAT THE PARENT OF A MINOR CONSUMER FOUND TWO PEN NEEDLES TO CLOG DURING THE INJECTION. ALSO, REPORTED THE GLUCOSE LEVEL TO BE A LITTLE ON THE HIGH SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1404615 PEN NDL 32G 4MM 100BX 1200 USA HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON AND CO. 320122 9294863 00382903201228

    Patients

    Seq Age Sex Outcome Treatment
    1 Other