BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II - 2-PIECE SYRINGE

    MDR report key: 16950902 · Received May 17, 2023

    Report

    Report Number
    3002682307-2023-00124
    Event Type
    Malfunction
    Date Received
    May 17, 2023
    Date of Event
    April 26, 2023
    Report Date
    August 15, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 26-JUNE-2023. H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309050 AND LOT NUMBER 2202138. 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, ONE (1) PHYSICAL SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY TEAM. HOWEVER, THROUGH INSPECTION OF THE SAMPLE, NO SIGNS OF DEFECT COULD BE IDENTIFIED. AS THE PROVIDED SAMPLE DID NOT PRESENT ANY FUNCTIONALITY ISSUE, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD DISCARDIT II - 2-PIECE SYRINGE EXPERIENCED PLUNGER MOVEMENT DIFFICULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HEREBY WISH TO REPORT A PROBLEM RECEIVED FROM US. END CUSTOMER (DOCTOR), USER OF DISCARDIT II SYRINGES (2,5,10ML) WITHOUT SILICONE. THE DOCTOR REPORTS A DIFFICULT AND POOR SLIDING OF THE PLUNGER IN THE SYRINGE WITH A "CLICK" AT THE END OF THE SYRINGE ITSELF WHICH DOES NOT ALLOW ADEQUATE AND CONTROLLED ADMINISTRATION OF THE DRUG TO THE PATIENT. THE DOCTOR STATES THAT HE HAS USED THESE TYPES OF SYRINGES BEFORE, BUT DIFFERENT BATCHES AND THAT HE HAS NOT HAD THESE PROBLEMS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD DISCARDIT II - 2-PIECE SYRINGE EXPERIENCED PLUNGER MOVEMENT DIFFICULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HEREBY WISH TO REPORT A PROBLEM RECEIVED FROM US. END CUSTOMER (DOCTOR), USER OF DISCARDIT II SYRINGES (2,5,10ML) WITHOUT SILICONE. THE DOCTOR REPORTS A DIFFICULT AND POOR SLIDING OF THE PLUNGER IN THE SYRINGE WITH A "CLICK" AT THE END OF THE SYRINGE ITSELF WHICH DOES NOT ALLOW ADEQUATE AND CONTROLLED ADMINISTRATION OF THE DRUG TO THE PATIENT. THE DOCTOR STATES THAT HE HAS USED THESE TYPES OF SYRINGES BEFORE, BUT DIFFERENT BATCHES AND THAT HE HAS NOT HAD THESE PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1380368 BD DISCARDIT II - 2-PIECE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2202138

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown