BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN 31X5 EUROPE BD BRAND

    MDR report key: 10598030 · Received September 29, 2020

    Report

    Report Number
    9616656-2020-00972
    Event Type
    Malfunction
    Date Received
    September 29, 2020
    Date of Event
    December 15, 2019
    Report Date
    September 28, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: LEVEL B INVESTIGATION. COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S2; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR NEEDLE BENT, DIFFICULT/UNABLE TO OPERATE & NEEDLE CLOG ON LOT # 8233910. A REVIEW OF RISK MANAGEMENT DOCUMENT (B)(4), INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (PEN NEEDLE, NEEDLE BENT, DIFFICULT/UNABLE TO OPERATE, NEEDLE CLOG) WAS CAPTURED AND ADDRESSED. INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF 4 MM, 32 G PEN NEEDLES. CUSTOMER STATES THAT THE PRODUCT IS JAMMED AND WHEN REMOVING THE NEEDLE IT IS BENT AND IT DID NOT RELEASE LIQUID. THE PHOTOS WERE EXAMINED AND EXHIBITED A BENT NON PATIENT END OF THE CANNULA, WHICH COULD PREVENT INSULIN FROM FLOWING THROUGH THE CANNULA PROPERLY. 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. INVESTIGATION CONCLUSION: 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. 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. ROOT CAUSE DESCRIPTION: USER ERROR. NO EVIDENCE OF MANUFACTURING RELATED ISSUES WERE OBSERVED. 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. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PN 31 X 5 EUROPE BD BRAND WAS JAMMED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320212, BATCH NO: 8233910. IT WAS REPORTED THAT THE PRODUCT IS JAMMED AND WHEN REMOVING THE NEEDLE IT IS BENT. VERBATIM: DESCRIPTION: DEVICE IS NOT APPLYING, IS JAMMED AND WHEN REMOVING THE NEEDLE IT IS BENT. PATIENT CONTACTED. WE ASKED ABOUT THE BENT NEEDLE AND ASKED TO DO ONE MORE TEST. WE ASKED HER TO CHECK THE NEEDLE BEFORE PUTTING IT IN THE DEVICE. SHE SAID IT WAS NORMAL. AFTER THE TEST, WHICH DID NOT RELEASE LIQUID AND WITH THE HARD BUTTON, THE NEEDLE WAS REMOVED AND THE PATIENT REPORTED THAT THE NEEDLE WAS SLIGHTLY BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066733 PN 31X5 EUROPE BD BRAND PEN NEEDLE FMI BECTON DICKINSON AND CO. 8233910

    Patients

    Seq Age Sex Outcome Treatment
    1 Other