BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEN NDL 32G 4MM HP 100 BOX 1200 CA

    MDR report key: 10478875 · Received September 1, 2020

    Report

    Report Number
    9616656-2020-00871
    Event Type
    Injury
    Date Received
    September 1, 2020
    Date of Event
    August 7, 2020
    Report Date
    September 21, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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: 9/17/2020. H.6. INVESTIGATION: CUSTOMER RETURNED (196) 32GX4MM BD PEN NEEDLES IN OPEN SHELF CARTONS FROM LOT 0063232 AND LOT 0084087. PHARMACIST STATED, CONSUMER REPORTED NON PATIENT END BENT WHEN TRYING TO ATTACH PEN NEEDLE TO PEN; STATED CONSUMER COULD NOT USE PEN NEEDLE; STATED, CONSUMERS BLOOD SUGAR WAS AFFECTED DUE TO NOT GETTING HER SHOT. OUT OF THE 196 RETURNED PEN NEEDLES, 13 WERE RETURNED AFTER USE. THESE 13 PEN NEEDLES WERE EXAMINED, AND IT WAS OBSERVED THAT 4 EXHIBITED BENT NON-PATIENT END (NPE) CANNULAS; THE OTHER 9 PEN NEEDLES WERE TESTED FOR FLOW USING A TEST PEN INJECTOR AND ALL 9 WERE ABLE TO EXPEL PROPERLY. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED ON THESE 13 SAMPLES. NEXT, 30 SAMPLES OUT OF THE REMAINING 183 SAMPLES RETURNED UNUSED WERE SELECTED, THEN TESTED FOR FLOW USING A TEST PEN INJECTOR: ALL 30 TESTED PEN NEEDLES WERE ABLE TO EXPEL PROPERLY. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED ON THESE SAMPLES. THE BENT NPE CANNULAS WOULD BE THE CAUSE FOR NO FLOW THROUGH THE PEN NEEDLES, HENCE, THE CONSUMER WOULD THINK THE PEN NEEDLES WERE CLOGGED (AS REPORTED). SINCE THE 4 PEN NEEDLES WITH BENT NPE CANNULAS 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 NEEDLE TO A PEN INJECTOR. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THESE PACKAGED LOTS CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. 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 AN UNSPECIFIED NUMBER OF PEN NDL 32G 4MM HP 100 BOX 1200 CA WERE UNABLE TO DELIVER INSULIN/MEDICATION DURING USE. IT IS BELIEVED THAT THE LAY USER/CONSUMER WENT TO THE EMERGENCY ROOM AFTER THE PRODUCT DEFECT AFFECTED THEIR BLOOD SUGAR LEVELS. NO INFORMATION IS CURRENTLY AVAILABLE REGARDING THE MEDICAL INTERVENTION OR ITS OUTCOME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FROM PHONE CALL: PHARMACIST STATED, CONSUMER REPORTED NON PATIENT END BENT WHEN TRYING TO ATTACH PEN NEEDLE TO PEN. STATED CONSUMER COULD NOT USE PEN NEEDLE. STATED, CONSUMERS BLOOD SUGAR WAS AFFECTED DUE TO NOT GETTING HER SHOT AND SHE THINKS THE CONSUMER WENT TO EMERGENCY ROOM. STATED, CONSUMER DOES NOT WANT TO CONTINUE USING NANO PRO, SO PHARMACY REPLACED NANO PRO WITH A DIFFERENT BRAND. PHARMACIST STATED, SHE WILL ASK CONSUMER TO CALL IN TO SPEAK MORE ABOUT COMPLAINT. LOT: 0063232 ,0084087. CATALOG: 320555. DATE OF EVENT: UNKNOWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(4). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0063232, MEDICAL DEVICE EXPIRATION DATE: 2025-02-28, DEVICE MANUFACTURE DATE: 2020-03-03, MEDICAL DEVICE LOT #: 0084087, MEDICAL DEVICE EXPIRATION DATE: 2025-03-31, DEVICE MANUFACTURE DATE: 2020-03-24.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PEN NDL 32G 4MM HP 100 BOX 1200 CA WERE UNABLE TO DELIVER INSULIN/MEDICATION DURING USE. IT IS BELIEVED THAT THE LAY USER/CONSUMER WENT TO THE EMERGENCY ROOM AFTER THE PRODUCT DEFECT AFFECTED THEIR BLOOD SUGAR LEVELS. NO INFORMATION IS CURRENTLY AVAILABLE REGARDING THE MEDICAL INTERVENTION OR ITS OUTCOME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FROM PHONE CALL: PHARMACIST STATED, CONSUMER REPORTED NON PATIENT END BENT WHEN TRYING TO ATTACH PEN NEEDLE TO PEN. STATED CONSUMER COULD NOT USE PEN NEEDLE. STATED, CONSUMERS BLOOD SUGAR WAS AFFECTED DUE TO NOT GETTING HER SHOT AND SHE THINKS THE CONSUMER WENT TO EMERGENCY ROOM. STATED, CONSUMER DOES NOT WANT TO CONTINUE USING NANO PRO, SO PHARMACY REPLACED NANO PRO WITH A DIFFERENT BRAND. PHARMACIST STATED, SHE WILL ASK CONSUMER TO CALL IN TO SPEAK MORE ABOUT COMPLAINT. LOT: 0063232 ,0084087. CATALOG: 320555. DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943231 PEN NDL 32G 4MM HP 100 BOX 1200 CA PEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention