BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II 10 ML SYRINGE

    MDR report key: 9812197 · Received March 10, 2020

    Report

    Report Number
    3002682307-2020-00092
    Event Type
    Malfunction
    Date Received
    March 10, 2020
    Date of Event
    February 19, 2020
    Report Date
    March 13, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY BD HAS NOT BEEN PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 300294 LOT 1910515 TO INVESTIGATE FOR THIS RECORD. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. THE MATERIAL USED TO MANUFACTURE DISCARDIT SYRINGES HAS BEEN SELECTED AND TESTED TO RESIST NORMAL CONDITIONS OF USE. THE ASSEMBLING MACHINES HAVE AN ON-LINE DETECTION SYSTEM THAT INSPECTS 100% THE SYRINGES, REJECTING AUTOMATICALLY THE SYRINGES WITH BROKEN PARTS LIKE THE BARREL OF THE SYRINGE. BASED ON THIS FACT, BD BELIEVES THAT THE SYRINGE BARREL COULD BREAK BECAUSE OF THE STRONG CONDITIONS DURING USE OF THE PRODUCT. THE DEVICE HISTORY REVIEW SHOWED NO INDICATION OF THE ALLEGED DEFECT. CONSIDERING OUR IN-COMING AND IN-PROCESS INSPECTION AND SINCE THIS IS THE FIRST TIME THIS LOT IS REPORTED FOR THIS DEFECT, NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD DISCARDIT¿ II 10 ML SYRINGE BARREL BROKE DURING USE. THIS OCCURRED ON 25 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCARDIT 10ML BARREL BREAKAGE WHILE ASPIRATING THE MEDICATION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD DISCARDIT¿ II 10 ML SYRINGE BARREL BROKE DURING USE. THIS OCCURRED ON 25 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCARDIT 10ML BARREL BREAKAGE WHILE ASPIRATING THE MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278282 BD DISCARDIT II 10 ML SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1910515

    Patients

    Seq Age Sex Outcome Treatment
    1 Other