BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK TIP

    MDR report key: 11032155 · Received December 17, 2020

    Report

    Report Number
    1213809-2020-00895
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Date of Event
    November 19, 2020
    Report Date
    December 7, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9241688, MEDICAL DEVICE EXPIRATION DATE: 2024-07-31, DEVICE MANUFACTURE DATE: (B)(4) 2019. MEDICAL DEVICE LOT #: 9247681, MEDICAL DEVICE EXPIRATION DATE: 2024-08-31, DEVICE MANUFACTURE DATE: (B)(6) 2019. MEDICAL DEVICE LOT #: 9081846, MEDICAL DEVICE EXPIRATION DATE: 2024-03-31, DEVICE MANUFACTURE DATE: (B)(6) 2019. MEDICAL DEVICE LOT #: 9108747, MEDICAL DEVICE EXPIRATION DATE: 2024-03-31, DEVICE MANUFACTURE DATE: (B)(4) 2019. (B)(4). INVESTIGATION SUMMARY: ONE PHOTO DISPLAYING TWO LOOSE 10ML SYRINGES WAS RECEIVED AND EVALUATED. IT WAS OBSERVED, BOTH SYRINGES HAD THE STOPPER WEDGED BETWEEN THE BOTTOM OF THE PLUNGER ROD AND THE BARREL WALL. THE JAMMED STOPPER CONDITION WAS REJECTABLE PER PRODUCT SPECIFICATION. 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. INVESTIGATION CONCLUSION: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE WITH THE PHOTOS PROVIDED. ROOT CAUSE DESCRIPTION: POTENTIAL ROOT CAUSE FOR THE JAMMED STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THE AQL FOR INCORRECT ASSEMBLY IS 0.65%. THE DEFECTIVE RATE IDENTIFIED IS 2 OUT OF 428,400, WHICH IS 0.0005%. BATCHES 9241688, 9247681, 9081846, 9108747 ARE CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. RATIONALE: NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STOPPERS ON BD SYRINGES WITH THE LUER-LOK¿ TIP WERE DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE PLUNGER RUBBER IS DEFORMED / CURLED ON BOTH SYRINGES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1494999 BD SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1