BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 ML BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 11316623 · Received February 11, 2021

    Report

    Report Number
    1213809-2021-00075
    Event Type
    Malfunction
    Date Received
    February 11, 2021
    Date of Event
    January 15, 2021
    Report Date
    February 2, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903059034
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MEDICAL DEVICE TYPE: A SECOND DEVICE TYPE OF FMI IS ALSO APPLICABLE. PMA/510(K)#: THERE ARE TWO RELEVANT PMA/510K)S THAT APPLY TO THE DEVICE: K980580 SYRINGE: NEEDLE: K951254. (B)(4). INVESTIGATION SUMMARY: ONE PHOTO OF A LOOSE 1ML SYRINGE WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THERE WAS A LENGTHWISE CRACK OUTSIDE THE GRAD LINES EXTENDING FROM THE 0.2ML TO THE 0.4ML MARKING. THE CRACKED BARREL WAS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE CRACKED BARREL DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 0142879 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. 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. INVESTIGATION CONCLUSION: POTENTIAL ROOT CAUSE FOR THE CRACKED BARREL DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. (B)(4). NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 0142879 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 1 ML BD SAFETYGLIDE" INSULIN SYRINGE WITH ATTACHED NEEDLE EXPERIENCED DEVICE DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210964 1 ML BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE PISTON SYRINGE; HYPODERMIC SINGLE LUMEN NEEDLE FMF BECTON DICKINSON MEDICAL SYSTEMS 0142879 00382903059034

    Patients

    Seq Age Sex Outcome Treatment
    1