BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE WITH DETACHED BD MICROLANCE¿ NEEDLE

    MDR report key: 17338713 · Received July 17, 2023

    Report

    Report Number
    3002682307-2023-00198
    Event Type
    Malfunction
    Date Received
    July 17, 2023
    Date of Event
    June 22, 2023
    Report Date
    October 12, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3. 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

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER (B)(4) AND LOT NUMBER 2110176. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS SAMPLES WERE UNAVAILABLE FOR RETURN, TWENTY (20) RETAINED SAMPLES WERE OBTAINED FROM THE MANUFACTURING FACILITY. UPON REVIEW, THE RETAINED SAMPLES DID NOT DISPLAY ANY SIGNS OF LEAKAGE. BASED ON THE PROVIDED FEEDBACK, IT IS POSSIBLE THAT THE REPORTED LEAKAGE RESULTED FROM DAMAGE IN THE PLUNGER COMPONENT. IF THIS INCIDENT WERE TO REOCCUR, WE WOULD GREATLY APPRECIATE THE OPPORTUNITY TO REVIEW THE AFFECTED SAMPLE. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 OF THE BD DISCARDIT¿ II SYRINGE WITH DETACHED BD MICROLANCE¿ NEEDLE ARE LEAKING DOWN THE WALLS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: I WOULD LIKE TO INFORM YOU OF THE DRAWBACKS THAT WE HAVE IDENTIFIED WITH BD'S 20ML SYRINGES. WHEN YOU DRINK LIQUIDS LIKE SSN 0.9% IT SPILLS DOWN THE WALLS. ADDITIONAL INFORMATION RECEIVED ON 30.JUN.2023. IN HOW MANY UNITS OF THE DEVICE WAS THE DEVIATION FOUND? A: APPROXIMATELY 10 UNITS. DOES THE LEAK OCCUR INTERNALLY WITHIN THE SYRINGE OR EXTERNALLY? A: INTERNALLY. IS THE SAMPLE RELATED TO THE INCIDENT AVAILABLE FOR ANALYSIS? IF SO, HOW MANY UNITS? A: WE DON'T HAVE IT BECAUSE THIS SYRINGE IS USED MOSTLY IN ONCOLOGY AND WHEN WE SEE A LEAK IT IS IMMEDIATELY RULED OUT DUE TO THE CYTOTOXIC RISK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 OF THE BD DISCARDIT¿ II SYRINGE WITH DETACHED BD MICROLANCE¿ NEEDLE ARE LEAKING DOWN THE WALLS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: I WOULD LIKE TO INFORM YOU OF THE DRAWBACKS THAT WE HAVE IDENTIFIED WITH BD'S 20ML SYRINGES. WHEN YOU DRINK LIQUIDS LIKE SSN 0.9% IT SPILLS DOWN THE WALLS (I ATTACH BATCH AND REFERENCE PHOTOS) __ ADDITIONAL INFORMATION RECEIVED ON 30.JUN.2023 ¿ IN HOW MANY UNITS OF THE DEVICE WAS THE DEVIATION FOUND? A: APPROXIMATELY 10 UNITS. ¿ DOES THE LEAK OCCUR INTERNALLY WITHIN THE SYRINGE OR EXTERNALLY? A: INTERNALLY. ¿ IS THE SAMPLE RELATED TO THE INCIDENT AVAILABLE FOR ANALYSIS? IF SO, HOW MANY UNITS? A: WE DON'T HAVE IT BECAUSE THIS SYRINGE IS USED MOSTLY IN ONCOLOGY AND WHEN WE SEE A LEAK IT IS IMMEDIATELY RULED OUT DUE TO THE CYTOTOXIC RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1715177 BD DISCARDIT¿ II SYRINGE WITH DETACHED BD MICROLANCE¿ NEEDLE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2110176

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown