BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II 10 ML SYRINGE

    MDR report key: 10112718 · Received June 2, 2020

    Report

    Report Number
    3002682307-2020-00176
    Event Type
    Malfunction
    Date Received
    June 2, 2020
    Date of Event
    May 12, 2020
    Report Date
    July 13, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 2020-07-12. H.6. INVESTIGATION SUMMARY : A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBERS 2001219 & 2001222. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS INCIDENT, FIFTEEN PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE RETURNED SAMPLES WERE TESTED AND LEAKAGE WAS OBSERVED. TWENTY ADDITIONAL RETAINED SAMPLES FOR EACH REPORTED LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR FURTHER TESTING. OF THE TWENTY RETAINED SAMPLES BELONGING TO LOT NUMBER 2001219, ONE RETAINED SAMPLE SHOWED SIGNS OF LEAKAGE. NO SIGNS OF LEAKAGE WERE OBSERVED FOR THE RETAINED SAMPLES BELONGING TO LOT NUMBER 2001222. IT HAS BEEN DETERMINED THAT THE LEAKAGE RESULTED FROM DAMAGE TO THE PLUNGER LIP COMPONENT. THIS TYPE OF DAMAGE CAN BE PRODUCED DURING THE ASSEMBLY PROCESS IF THERE IS A MISALIGNMENT WITHIN THE PLUNGER ASSEMBLY STATION. THIS TYPE OF DEFECT SHOULD BE DETECTED WITH THE FAULTY PRODUCT DISCARDED. IN RESPONSE TO THIS INCIDENT, A QUALITY ALERT HAS BEEN ISSUED TO THE PRODUCTION FLOOR TO PREVENT THIS ISSUE FROM RECURRING AND TO DETECT AND DISCARD THE FAULTY PRODUCT IF THE MISALIGNMENT WERE TO REOCCUR. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD DISCARDIT¿ II 10 ML SYRINGES EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SYRINGE DRAWS AIR AND WHEN THE SYRINGE IS USED, LIQUID ESCAPES ON BOTH SIDES. IF A MISTAKE WAS ALREADY DISCOVERED WHILE TAKING THE MEDICATION, THE SYRINGE WAS DISCARDED, INCLUDING THE MEDICATION. IF THE ERROR OCCURRED WHEN INITIATING/USING THE SYRINGE, THE MEDICATION WAS CHANGED IMMEDIATELY IF POSSIBLE OR THE MEDICATION WAS RE-DOSED AND THE SYRINGE THEN DISCARDED.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD DISCARDIT¿ II 10 ML SYRINGES EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SYRINGE DRAWS AIR AND WHEN THE SYRINGE IS USED, LIQUID ESCAPES ON BOTH SIDES. IF A MISTAKE WAS ALREADY DISCOVERED WHILE TAKING THE MEDICATION, THE SYRINGE WAS DISCARDED, INCLUDING THE MEDICATION. IF THE ERROR OCCURRED WHEN INITIATING/USING THE SYRINGE, THE MEDICATION WAS CHANGED IMMEDIATELY IF POSSIBLE OR THE MEDICATION WAS RE-DOSED AND THE SYRINGE THEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571611 BD DISCARDIT II 10 ML SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2001219

    Patients

    Seq Age Sex Outcome Treatment
    1 Other