BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE PEN NEEDLE

    MDR report key: 10473453 · Received August 31, 2020

    Report

    Report Number
    9616656-2020-00863
    Event Type
    Malfunction
    Date Received
    August 31, 2020
    Date of Event
    August 6, 2020
    Report Date
    August 12, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (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 5TH RELATED COMPLAINT FOR NEEDLE CLOG THE 2ND RELATED COMPLAINT FOR NEEDLE MISSING AND THE 1ST RELATED COMPLAINT FOR FOREIGN MATTER ON LOT # 7032841. A REVIEW OF RISK MANAGEMENT DOCUMENT (B)(4) INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (PEN NEEDLE, NEEDLE CLOG, FOREIGN MATTER) IN APPLICABLE FILE WAS CAPTURED AND ADDRESSED. FOREIGN MATTER HAZARD MAPPED UNDER OTHER LISTED HAZARDS (CONTAMINATED) IN APPLICABLE FILE. A REVIEW OF DOCUMENT (B)(4) INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (PEN NEEDLE, NEEDLE MISSING) WAS CAPTURED AND ADDRESSED. INVESTIGATION SUMMARY: CUSTOMER RETURNED ONE (1) USED 32 G X 4 MM BD PEN NEEDLE WITHOUT A TEAR DROP LABEL ATTACHED. CUSTOMER REPORTED FINDING PEN NEEDLES IN CURRENT BOX THAT HAVE THE NEEDLE MISSING OR JUST A SMALL AMOUNT OF WIRE THERE, THE NEEDLE IS NOT DELIVERING THE INSULIN. THE RETURNED PEN NEEDLE WAS EXAMINED, AND IT WAS OBSERVED THAT THE NON-PATIENT END (NPE) CANNULA WAS BROKEN. NO FOREIGN MATTER WAS OBSERVED. 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 THE PEN NEEDLE WAS RETURNED AFTER USE, AND NO MANUFACTURING DEFECTS WERE OBSERVED, THE PROBABLE CAUSE OF THE BROKEN NPE CANNULA 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 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 (NPE CANNULA BROKEN). UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (FOREIGN MATTER). 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: THE POSSIBLE ROOT CAUSE FOR THIS ISSUE (NPE CANNULA BROKEN) 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. ROOT CAUSE COULD NOT BE DETERMINED AS THE REPORTED ISSUE (FOREIGN MATTER) IS UNCONFIRMED. 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 THE BD ULTRA-FINE¿ PEN NEEDLE WERE UNABLE TO DELIVER INSULIN/MEDICATION AND FOREIGN MATTER CONTAMINATION. PRODUCT DEFECTS WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320144, BATCH NO: 7032841. RETURNED CONSUMER'S PHONE CALL FROM VOICEMAIL THAT WAS RECEIVED. CONSUMER STATED HE IS FINDING PEN NEEDLES IN CURRENT BOX THAT HAVE THE NEEDLE MISSING OR JUST A SMALL AMOUNT OF WIRE THERE. STATED HE PRIMES AND THEN NOTHING COMES OUT. DATE OF EVENT: UNKNOWN. RECEIVED VOICEMAIL FROM CONSUMER WITH BD NEEDLE COMPLAINT. CONSUMER STATED SEVERAL NEEDLES HAVE NO NEEDLE IN THE UNIT OR A SMALL PIECE OF METAL. THEREFORE, THE NEEDLE IS NOT DELIVERING THE INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939608 BD ULTRA-FINE PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. 7032841

    Patients

    Seq Age Sex Outcome Treatment
    1 Other