BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM

    MDR report key: 9194029 · Received October 15, 2019

    Report

    Report Number
    9616656-2019-00996
    Event Type
    Malfunction
    Date Received
    October 15, 2019
    Date of Event
    September 30, 2019
    Report Date
    October 31, 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

    H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED SIX (6) USED 32G X 4MM BD PEN NEEDLES WITHOUT TEAR DROP LABELS ATTACHED. SPOUSE OF A CONSUMER REPORTED MISSING NEEDLES ON NON-PATIENT END; WHEN NOTHING CAME OUT DURING THE PRIMING WHEN CONSUMER REMOVED THE PEN NEEDLE AND NOTICE MISSING CANNULA ON NON-PATENT END. ALL SIX RETURNED PEN NEEDLES WERE EXAMINED, AND THE FOLLOWING WAS OBSERVED: FOUR WITH BENT NON-PATIENT END (NPE) CANNULAS. ONE WITH A BROKEN NPE CANNULA. ONE WITH A STRAIGHT NPE CANNULA. NO EVIDENCE OF MANUFACTURING DEFECTS WAS OBSERVED ON THE RETURNED PEN NEEDLES. SINCE ALL SIX PEN NEEDLES WERE RETURNED AFTER USE, AND NO MANUFACTURING DEFECTS WERE OBSERVED, THE PROBABLE CAUSE OF THE BENT OR BROKEN 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: (9071899) CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BENT NPE CANNULA, 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 12 PEN NDL 32G 4MM EXPERIENCED A FAILURE TO DELIVER INSULIN/MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320883; BATCH NO: 9071899. SPOUSE OF A CONSUMER REPORTED MISSING NEEDLES ON NON PATIENT END. WHEN NOTHING CAME OUT DURING THE PRIMING WHEN CONSUMER REMOVED THE PEN NEEDLE AND NOTICE MISSING CANNULA ON NON PATENT END. DURING THE PAST 3 DAYS. SHE HAS BEEN A JUVENILE DIABETIC. CONSUMER DOES THE PRIMING, SHE VISUALLY SEE THE NEEDLE IS STRAIGHT. EXPIRATION 2024-03-31. INCIDENT DATE: UNKNOWN. OCCURENCE: 12.

    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 12 PEN NDL 32G 4MM EXPERIENCED A FAILURE TO DELIVER INSULIN/MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320883 BATCH NO: 9071899. VERBATIM: SPOUSE OF A CONSUMER REPORTED MISSING NEEDLES ON NON PATIENT END. WHEN NOTHING CAME OUT DURING THE PRIMING WHEN CONSUMER REMOVED THE PEN NEEDLE AND NOTICE MISSING CANNULA ON NON PATENT END. DURING THE PAST 3 DAYS. SHE HAS BEEN A JUVENILE DIABETIC. CONSUMER DOES THE PRIMING, SHE VISUALLY SEE THE NEEDLE IS STRAIGHT. EXPIRATION 2024-03-31. INCIDENT DATE: UNKNOWN. OCCURENCE: 12.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983840 PEN NDL 32G 4MM HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 9071899 10885403897511

    Patients

    Seq Age Sex Outcome Treatment
    1 Other