BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3ML BD PLASTIPAK¿ SYRINGE LUER-LOK¿ TIP

    MDR report key: 14829453 · Received June 27, 2022

    Report

    Report Number
    1213809-2022-00358
    Event Type
    Malfunction
    Date Received
    June 27, 2022
    Date of Event
    May 30, 2022
    Report Date
    July 15, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096589
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). 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: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 07-JUL-2022. H6: INVESTIGATION SUMMARY: FORTY-FIVE 3ML SYRINGES (P/N 309658) IN BLISTER PACKAGES FROM BATCH 9242839 WERE RECEIVED AND EVALUATED. FIVE SYRINGES WERE OBSERVED TO HAVE AN ANGLED STOPPER WHICH WAS MEASURED AGAINST SPECIFICATION AND FOUND WITHIN TOLERANCE LIMIT. THE SAMPLES RECEIVED WERE WITH IN THE ACCEPTABLE SPECIFICATION LIMIT FOR STOPPER ANGULARITY; THEREFORE A ROOT CAUSE CANNOT BE ESTABLISHED, AND CORRECTIVE ACTIONS ARE NOT NECESSARY. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 9242839. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AT LEAST 5 3ML BD PLASTIPAK¿ SYRINGE LUER-LOK¿ TIPS EXPERIENCED DAMAGED STOPPERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN AT LEAST FIVE SYRINGES OF THIS BATCH, THE BLACK TOP OF THE SYRINGE PLUNGER DOES NOT HAVE A STRAIGHT SURFACE. THIS SEEMS TO BE DUE TO THE FACT THAT THE BLACK TOP OF THE SYRINGE PLUNGER DOES NOT HAVE THE SAME THICKNESS EVERYWHERE. AS A RESULT, IT IS NOT POSSIBLE TO PRECISELY DRAW UP A CERTAIN VOLUME. DUE TO THE VARYING THICKNESS OF THE SYRINGE PLUNGER ATTACHMENT, THERE IS A DEVIATION IN THE READ VOLUME OF UP TO 0.05 ML WHEN THE SYRINGE PLUNGER IS ROTATED AROUND ITSELF.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AT LEAST 5 3ML BD PLASTIPAK¿ SYRINGE LUER-LOK¿ TIPS EXPERIENCED DAMAGED STOPPERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN AT LEAST FIVE SYRINGES OF THIS BATCH, THE BLACK TOP OF THE SYRINGE PLUNGER DOES NOT HAVE A STRAIGHT SURFACE. THIS SEEMS TO BE DUE TO THE FACT THAT THE BLACK TOP OF THE SYRINGE PLUNGER DOES NOT HAVE THE SAME THICKNESS EVERYWHERE. AS A RESULT, IT IS NOT POSSIBLE TO PRECISELY DRAW UP A CERTAIN VOLUME. DUE TO THE VARYING THICKNESS OF THE SYRINGE PLUNGER ATTACHMENT, THERE IS A DEVIATION IN THE READ VOLUME OF UP TO 0.05 ML WHEN THE SYRINGE PLUNGER IS ROTATED AROUND ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2029845 3ML BD PLASTIPAK¿ SYRINGE LUER-LOK¿ TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9242839 00382903096589

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown