BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK DISPOSABLE SYRINGE

    MDR report key: 8514276 · Received April 15, 2019

    Report

    Report Number
    1213809-2019-00440
    Event Type
    Malfunction
    Date Received
    April 15, 2019
    Date of Event
    March 26, 2019
    Report Date
    May 10, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT WAS SENT IN ERROR. THE ISSUE WITH VOLUMETRIC ACCURACY WAS NOT A MALFUNCTION, BUT A REQUEST FOR INFORMATION HE ONLY WANTED TO KNOW THE EXACT VOLUME ACCURACY OF EACH PRODUCED BATCH. THE SYRINGES MET THE SPECIFICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD LUER-LOK¿ DISPOSABLE SYRINGE THERE IS A VARIATION IN THE SPRAY VOLUME BETWEEN DIFFERENT BATCHES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I MYSELF WORK AS A RESEARCHER AT PROQR AND AT THE MOMENT WE ARE DOING RESEARCH INTO RARE EYE DISEASES, AMONG OTHER THINGS. FOR THIS WE USE 1 ML SYRINGES. DURING OUR INVESTIGATION WE NOTICED THAT THERE IS A VARIATION IN THE SPRAY VOLUME BETWEEN DIFFERENT BATCHES (LOT # 8150821, 6305936 AND 8026687) AND THAT SOME BATCHES ARE MORE ACCURATE THAN OTHERS. THE VARIATION FALLS WITHIN THE SPECIFIED SPECIFICATIONS BUT FOR OUR PURPOSES WE WANT TO INJECT AS ACCURATELY AS POSSIBLE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8150821; MEDICAL DEVICE EXPIRATION DATE: 2023-05-31; DEVICE MANUFACTURE DATE: 2018-06-18; MEDICAL DEVICE LOT #: 6305936; MEDICAL DEVICE EXPIRATION DATE: 2021-10-31; DEVICE MANUFACTURE DATE: 2016-12-08; MEDICAL DEVICE LOT #: 8026687; MEDICAL DEVICE EXPIRATION DATE: 2023-01-31; DEVICE MANUFACTURE DATE: 2018-02-22. (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BD LUER-LOK¿ DISPOSABLE SYRINGE THERE IS A VARIATION IN THE SPRAY VOLUME BETWEEN DIFFERENT BATCHES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I MYSELF WORK AS A RESEARCHER AT (B)(6) AND AT THE MOMENT WE ARE DOING RESEARCH INTO RARE EYE DISEASES, AMONG OTHER THINGS. FOR THIS WE USE 1 ML SYRINGES. DURING OUR INVESTIGATION WE NOTICED THAT THERE IS A VARIATION IN THE SPRAY VOLUME BETWEEN DIFFERENT BATCHES (LOT # 8150821, 6305936 AND 8026687) AND THAT SOME BATCHES ARE MORE ACCURATE THAN OTHERS. THE VARIATION FALLS WITHIN THE SPECIFIED SPECIFICATIONS BUT FOR OUR PURPOSES WE WANT TO INJECT AS ACCURATELY AS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309393 BD LUER-LOK DISPOSABLE SYRINGE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other