BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE

    MDR report key: 13861900 · Received March 23, 2022

    Report

    Report Number
    3003152976-2022-00112
    Event Type
    Malfunction
    Date Received
    March 23, 2022
    Date of Event
    February 24, 2022
    Report Date
    March 30, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 28-MAR-2022. H6: INVESTIGATION SUMMARY: SEVERAL SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, THE BARREL WAS OBSERVED TO BE DAMAGED, VERIFYING THE REPORTED ISSUE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2110020, FINDING ONE ANNOTATION RELATED TO THE ALLEGED DEFECT. DURING THE MARKING PROCESS, IT WAS IDENTIFIED THE MARKING MACHINE WAS PERIODICALLY CAUSING DAMAGE TO THE PRODUCT AS OBSERVED IN THE SAMPLE PROVIDED. A PROJECT WAS IMMEDIATELY INITIATED TO RESOLVE THE ISSUE, REPLACING PARTS WITHIN THE MARKING MACHINE AND IMPROVED INSPECTIONS WERE PERFORMED, AS WELL AS INCREASING INSPECTION FREQUENCIES TO BETTER IDENTIFY IMPACTED PRODUCT. BASED ON OUR INVESTIGATION IT WAS DETERMINED THIS INCIDENT IS RELATED TO THE ISSUE IDENTIFIED DURING MANUFACTURING, THIS SAMPLE NOT BEING PROPERLY IDENTIFIED AND DISCARDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A KINK IN THE BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE BARREL CAUSED LIQUID TO LEAK PAST THE STOPPER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IN OUR ORDER THIS WEEK WE RECEIVED A BOX OF 10ML SYRINGES WHICH ARE FAULTY (LOT2110020). THERE IS A KINK IN THE BARREL OF THE SYRINGE, WHICH THEN ALLOWS LIQUID TO ESCAPE OUTWITH THE BLACK PLUNGER. ESSENTIALLY, THEY CANNOT BE USED".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A KINK IN THE BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE BARREL CAUSED LIQUID TO LEAK PAST THE STOPPER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IN OUR ORDER THIS WEEK WE RECEIVED A BOX OF 10ML SYRINGES WHICH ARE FAULTY (LOT2110020). THERE IS A KINK IN THE BARREL OF THE SYRINGE, WHICH THEN ALLOWS LIQUID TO ESCAPE OUTWITH THE BLACK PLUNGER. ESSENTIALLY, THEY CANNOT BE USED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1129068 BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2110020

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown