BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE INSULIN SYRINGE

    MDR report key: 9700283 · Received February 12, 2020

    Report

    Report Number
    1920898-2020-00122
    Event Type
    Malfunction
    Date Received
    February 12, 2020
    Date of Event
    January 23, 2020
    Report Date
    February 25, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED (10) 30GX8MM, 1ML BD INSULIN SYRINGES IN A SEALED POLYBAG FROM LOT 9182225. CONSUMER REPORTED INSIDE THE SEALED PACKAGE OF MATERIAL THERE IS A SYRINGE WITH THE NEEDLE UNCOVERED; THE PROTECTOR IS LOOSE IN THE PACKAGING. THE RETURNED POLYBAG WAS EXAMINED AND IT WAS OBSERVED THAT ONE OF THE SYRINGES INSIDE HAD A CANNULA SHIELD THAT WAS SEPARATED FROM THE SYRINGE ASSEMBLY. THE SEPARATED CANNULA SHIELD WAS ALSO INSIDE THE POLYBAG. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9182225. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. INVESTIGATION CONCLUSION: 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: MAINTENANCE DISPATCH #73025 WAS ENTERED FOR PEASHOOTER JAMS. THIS PEASHOOTER CONVEYS THE SHIELDED PRODUCT TO THE NEXT OPERATION. WHEN THE PEASHOOTER JAMS, SHIELDS CAN BE KNOCKED LOOSE. THE PROBLEM WAS FIXED BY ADJUSTING THE POSITION OF THE KICKER BRACKET. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ INSULIN SYRINGE NEEDLE WAS UNCOVERED INSIDE THE PACKAGING BEFORE USE, AND THE PROTECTOR WAS LOOSE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: "INSIDE THE SEALED PACKAGE OF MATERIAL THERE IS A SYRINGE WITH THE NEEDLE UNCOVERED. THE PROTECTOR IS LOOSE IN THE PACKAGING. THERE WAS ACCIDENTAL PUNCTURE WITH THE CLEAN NEEDLE. NO DAMAGE OR INTERVENTION."

    Additional Manufacturer Narrative · 1

    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 THE BD ULTRA-FINE¿ INSULIN SYRINGE NEEDLE WAS UNCOVERED INSIDE THE PACKAGING BEFORE USE, AND THE PROTECTOR WAS LOOSE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "INSIDE THE SEALED PACKAGE OF MATERIAL THERE IS A SYRINGE WITH THE NEEDLE UNCOVERED. THE PROTECTOR IS LOOSE IN THE PACKAGING. THERE WAS ACCIDENTAL PUNCTURE WITH THE CLEAN NEEDLE. NO DAMAGE OR INTERVENTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166965 BD ULTRA-FINE INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9182225

    Patients

    Seq Age Sex Outcome Treatment
    1 Other