BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 30GA 1/2IN

    MDR report key: 10165987 · Received June 17, 2020

    Report

    Report Number
    3002682307-2020-00188
    Event Type
    Malfunction
    Date Received
    June 17, 2020
    Date of Event
    May 27, 2020
    Report Date
    June 23, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 180930. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT AND ALL INSPECTIONS WERE FOUND TO BE WITHIN SPECIFICATION. AS SAMPLES WERE UNAVAILABLE FOR THIS RECORD, TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR FURTHER INVESTIGATION. THE RETAINED SAMPLES WERE ASSEMBLED WITH A CAVERJECT SYRINGE FOLLOWING THE CAVERJET KIT INSTRUCTIONS. THE HUB WAS POSITIONED WITHIN THE SYRINGE TIP WITH A SLIGHTLY ROTATIONAL MOVEMENT. ALL OF THE RETAINED SAMPLES FIT PER SPECIFICATION WITHIN THE SYRINGE TIP WITH NO SIGNS OF LEAKAGE WERE OBSERVED. IT IS POSSIBLE THAT THIS INCIDENT RESULTED DUE TO INCORRECT LUER DIMENSIONS OR DAMAGE TO THE SYRINGE TIP, HOWEVER, WITHOUT THE SAMPLE INVOLVED IN THE INCIDENT, THOSE DEFECTS CANNOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEEDLES 30GA 1/2IN EXPERIENCED A NEEDLE THAT WAS LOOSE/PULLED OUT OF HUB AND A DEFECTIVE NEEDLE. PRODUCT DEFECTS WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED A NEW CUSTOMER COMPLAINT FOR A NEEDLE QUALITY PROBLEM ("IT FITS, BUT HAS NO FIXATION. LOOSENS WHEN APPLYING / INJECTING THE LIQUID"). LOT OF IMPACTED 30G NEEDLES: SUPPLIER LOT: 180930, REFERENCE: 304000. THIS IS THE 5TH CLAIM IMPACTING LOT 19030052.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEEDLES 30 GA 1/2 IN EXPERIENCED A NEEDLE THAT WAS LOOSE/PULLED OUT OF HUB AND A DEFECTIVE NEEDLE. PRODUCT DEFECTS WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED A NEW CUSTOMER COMPLAINT FOR A NEEDLE QUALITY PROBLEM ("IT FITS, BUT HAS NO FIXATION. LOOSENS WHEN APPLYING / INJECTING THE LIQUID"). LOT OF IMPACTED 30 G NEEDLES: SUPPLIER LOT: 180930, REFERENCE: 304000. THIS IS THE 5TH CLAIM IMPACTING LOT 19030052.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629820 NEEDLE 30GA 1/2IN NEEDLE FMI BECTON DICKINSON, S.A. 180930

    Patients

    Seq Age Sex Outcome Treatment
    1 Other