BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE 20ML

    MDR report key: 14639566 · Received June 8, 2022

    Report

    Report Number
    3002682307-2022-00157
    Event Type
    Malfunction
    Date Received
    June 8, 2022
    Date of Event
    April 25, 2022
    Report Date
    November 7, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, 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: 21-OCT-2022 . H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 300296 AND LOT NUMBER 2202167. 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. TO AID IN THE INVESTIGATION OF THIS ISSUE, THE AFFECTED SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLE, LEAKAGE WAS OBSERVED. TWENTY RETAINED SAMPLES WERE ALSO OBTAINED FOR EVALUATION; HOWEVER, THE RETAINED SAMPLES DID NOT SHOW ANY SIGNS OF LEAKAGE. BASED ON THE RETURNED SAMPLE RESULTS, THE LEAKAGE RESULTED FROM DAMAGE TO THE PLUNGER LIP COMPONENT. THIS TYPE OF DAMAGE MAY OCCUR DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR WITHIN THE PLUNGER ASSEMBLY MACHINE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT DURING USE THE INJECTION OF THE PRODUCT INFILTRATED THE BODY OF THE BD DISCARDIT¿ II SYRINGE 20ML ON THE PLUNGER SIDE, WITH A LOSS OF APPROXIMATELY 1ML OF PRODUCT, FROM WHICH THE PATIENT DID NOT BENEFIT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE WITHDRAWAL OF MEDICATION (LIORESAL) BY SYRINGE WAS CARRIED OUT WITHOUT ANY PROBLEM, BUT THE INJECTION OF THE SAME PRODUCT WITH THE SYRINGE INTO THE RESERVOIR OF AN IMPLANTABLE PROGRAMMABLE INFUSION PUMP POSED THE FOLLOWING PROBLEM: DURING THE INJECTION THE PRODUCT INFILTRATED THE BODY OF THE SYRINGE ON THE PLUNGER SIDE, WITH A LOSS OF APPROXIMATELY 1ML OF PRODUCT, FROM WHICH THE PATIENT DID NOT BENEFIT."

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT DURING USE THE INJECTION OF THE PRODUCT INFILTRATED THE BODY OF THE BD DISCARDIT¿ II SYRINGE 20ML ON THE PLUNGER SIDE, WITH A LOSS OF APPROXIMATELY 1ML OF PRODUCT, FROM WHICH THE PATIENT DID NOT BENEFIT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE WITHDRAWAL OF MEDICATION (LIORESAL) BY SYRINGE WAS CARRIED OUT WITHOUT ANY PROBLEM, BUT THE INJECTION OF THE SAME PRODUCT WITH THE SYRINGE INTO THE RESERVOIR OF AN IMPLANTABLE PROGRAMMABLE INFUSION PUMP POSED THE FOLLOWING PROBLEM: DURING THE INJECTION THE PRODUCT INFILTRATED THE BODY OF THE SYRINGE ON THE PLUNGER SIDE, WITH A LOSS OF APPROXIMATELY 1ML OF PRODUCT, FROM WHICH THE PATIENT DID NOT BENEFIT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678758 BD DISCARDIT¿ II SYRINGE 20ML PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2202167

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown