BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 16740446 · Received April 13, 2023

    Report

    Report Number
    3002682307-2023-00098
    Event Type
    Malfunction
    Date Received
    April 13, 2023
    Date of Event
    March 27, 2023
    Report Date
    June 5, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309050 AND LOT NUMBERS 2210141 AND 2211176. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS FOR EITHER LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THIS REPORT OF MIXED PRODUCT. ALL QUALITY TESTS AND INSPECTIONS WERE FOUND TO BE WITHIN SPECIFICATION. AT THIS TIME, WE ARE UNABLE TO IDENTIFY AN EXACT CAUSE FOR THIS REPORTED INCIDENT. THERE IS A 100% INSPECTION PROCESS WHICH CHECKS SHELF CARTON INFORMATION TO PREVENT MIXED PRODUCT OR MISSING INFORMATION. WE BELIEVE THAT THIS DEFECT COULD HAVE RESULTED DUE TO A REINTRODUCTION OF MATERIAL AFTER INSPECTION. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT 7200 OF THE BD DISCARDIT¿ II SYRINGE EXPERIENCED MIXED PRODUCT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: WE WERE SUPPLIED BY BD WITH MIXED BATCHES. THE OUTER CARTONS WERE MARKED WITH BATCH 2210141 BUT CONTAINED GOODS (CU) FROM BATCH 2210141 AND BATCH 2211176.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 7200 OF THE BD DISCARDIT¿ II SYRINGE EXPERIENCED MIXED PRODUCT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: WE WERE SUPPLIED BY BD WITH MIXED BATCHES. THE OUTER CARTONS WERE MARKED WITH BATCH 2210141 BUT CONTAINED GOODS (CU) FROM BATCH 2210141 AND BATCH 2211176.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979005 BD DISCARDIT¿ II SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2210141

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown