BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 16989836 · Received May 23, 2023

    Report

    Report Number
    3002682307-2023-00132
    Event Type
    Malfunction
    Date Received
    May 23, 2023
    Date of Event
    May 2, 2023
    Report Date
    August 14, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 07-AUG-2023 . H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 300296 AND LOT NUMBER 2110189. 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, FOUR (4) SAMPLE UNITS WERE RETURNED FOR EVALUATION. HOWEVER, THROUGH INSPECTION OF THE SAMPLES, NO SIGNS OF DEFECT WERE OBSERVED. THE PROVIDED SAMPLES DID NOT DISPLAY ANY FUNCTIONALITY ISSUE. THE MEDICATION USED OR A SPECIAL METHOD OF HANDLING (HIGH TEMPERATURES, PRESSURES, SEVERAL USES, ETC.) COULD AFFECT THE FUNCTIONALITY OF THE SYRINGE. AT THIS TIME, AN EXACT CAUSE COULD NOT BE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    H.3. 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 THE BD DISCARDIT¿ II SYRINGE LEAKED DURING THE BLOOD COLLECTION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE: "STUCK PLUNGER, AIR ENTRY. "WE HAVE HAD SEVERAL COMPLAINTS FROM CUSTOMERS REGARDING BD BRAND 10ML AND 20ML SYRINGES. THEY COMPLAIN OF STUCK PLUNGERS, AIR ENTRY, AND IF THEY DO NOT PLACE THE SYRINGE IN AN UPRIGHT POSITION WHEN POSITIONING THE SYRINGE TOWARDS THE COLLECTION TUBE THERE ARE SEVERAL DRIPS ON THE FLOOR." SYRINGES ARE USED IN CLINICAL LABORATORIES FOR BLOOD COLLECTION."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD DISCARDIT¿ II SYRINGE LEAKED DURING THE BLOOD COLLECTION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE: "STUCK PLUNGER, AIR ENTRY. "WE HAVE HAD SEVERAL COMPLAINTS FROM CUSTOMERS REGARDING BD BRAND 10ML AND 20ML SYRINGES. THEY COMPLAIN OF STUCK PLUNGERS, AIR ENTRY, AND IF THEY DO NOT PLACE THE SYRINGE IN AN UPRIGHT POSITION WHEN POSITIONING THE SYRINGE TOWARDS THE COLLECTION TUBE THERE ARE SEVERAL DRIPS ON THE FLOOR." SYRINGES ARE USED IN CLINICAL LABORATORIES FOR BLOOD COLLECTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1552871 BD DISCARDIT¿ II SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2110189

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown