BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML LL BNS

    MDR report key: 11558145 · Received March 23, 2021

    Report

    Report Number
    1213809-2021-00154
    Event Type
    Malfunction
    Date Received
    March 23, 2021
    Date of Event
    February 25, 2021
    Report Date
    May 4, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-04-19. H6: INVESTIGATION SUMMARY: TWO PHOTOS AND TEN 5ML SYRINGES WITH WHITE TIP CAPS ATTACHED IN UNKNOWN PACKAGING WERE RECEIVED AND EVALUATED. BOTH PHOTOS EACH DISPLAYED A LOOSE 5ML SYRINGE WITH APPROXIMATELY 3ML OF OPAQUE WHITE FLUID INSIDE. IT WAS OBSERVED IN THE PHOTOS A SMALL AMOUNT OF FLUID WAS PRESENT BETWEEN THE RIBS OF THE STOPPER. THE PHYSICAL SAMPLES WERE VISUALLY INSPECTED WITH NO DEFECTS OBSERVED. LEAKAGE TESTING WAS PERFORMED ON ALL TEN OF THE RECEIVED SYRINGES. NO LEAKAGE OCCURRED WITH ANY OF THE SAMPLE. POTENTIAL ROOT CAUSE FOR THE LEAKAGE PAST STOPPER DEFECT COULD NOT BE DETERMINED. THE DEFECT WAS ONLY PRESENT IN THE PHOTOS AND WAS NOT REPLICATED DURING TESTING OF THE PHYSICAL SAMPLES. ADDITIONALLY, IT WAS UNCLEAR WHAT CONDITIONS THE SYRINGES IN THE PHOTOS WERE SUBJECTED TO. THESE SYRINGES ARE SOLD AS NON-STERILE, AND THE RETURNED SAMPLES WERE RECEIVED IN UNKNOWN STERILE PACKAGING. SINCE ROOT CAUSE COULD NOT BE DEFINED, NO CORRECTIVE ACTIONS ARE NECESSARY AT THIS TIME. 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 8 SYRINGE 5ML LL BNS EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED A COMPLAINT FROM OUR CUSTOMER DUE TO FLUID LEAKING PAST THE BUNG WHEN PREPARING DRUGS FOR CHEMOTHERAPY. THIS ISSUE HAS OCCURRED ON 6 OCCASIONS WITH SYRINGES FROM LOT 0223034 AND 2 OCCASIONS WITH SYRINGES FROM LOT 0184824.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0223034. MEDICAL DEVICE EXPIRATION DATE: 2025-07-31. DEVICE MANUFACTURE DATE: 2020-08-10. MEDICAL DEVICE LOT #: 0184824. MEDICAL DEVICE EXPIRATION DATE: 2025-06-30. DEVICE MANUFACTURE DATE: 2020-07-02.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 8 SYRINGE 5ML LL BNS EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED A COMPLAINT FROM OUR CUSTOMER DUE TO FLUID LEAKING PAST THE BUNG WHEN PREPARING DRUGS FOR CHEMOTHERAPY. THIS ISSUE HAS OCCURRED ON 6 OCCASIONS WITH SYRINGES FROM LOT 0223034 AND 2 OCCASIONS WITH SYRINGES FROM LOT 0184824.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446621 SYRINGE 5ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 0184824

    Patients

    Seq Age Sex Outcome Treatment
    1