BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II SYRINGE W/O NEEDLE

    MDR report key: 9112665 · Received September 24, 2019

    Report

    Report Number
    3002682307-2019-00515
    Event Type
    Malfunction
    Date Received
    September 24, 2019
    Date of Event
    September 4, 2019
    Report Date
    October 2, 2019
    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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAS BEEN PROVIDED WITH SAMPLE FOR CATALOG 300296 LOT 1905231 TO INVESTIGATE FOR THIS RECORD. THE REPORTED LINES WERE IDENTIFIED IN THESE PROVIDED SAMPLES, NO FUNCTIONALITY ISSUE WAS FOUND. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE OF HAIRLINE CRACKS IN THE SYRINGE BARREL. THE REPORTED DEFECT WAS PRODUCED BY IMPROPER INJECTION IN THE BARREL FILLING PHASE. IT COULD OCCUR CAUSE IF THERE IS A PARTICLE INSIDE THE MOLD THAT PRODUCES STRIPES IN THE INTERNAL WALL OF THE BARREL. IN EXTREME CASES, THAT ISSUE COULD PRODUCE FUNCTIONALITY PROBLEMS DURING THE USE OF THE SYRINGE. OTHERWISE, THE ASSEMBLING MACHINES HAVE AN ON-LINE DETECTION SYSTEM THAT INSPECTS 100% THE SYRINGES, REJECTING AUTOMATICALLY THE SYRINGES WITH BROKEN PARTS LIKE THE TIP OF THE BARREL. BASED ON THIS FACT, BD BELIEVES THAT NO FUNCTIONALITY ISSUE AFFECTED THE REPORTED PRODUCT. DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD DISCARDIT¿ II SYRINGE W/O NEEDLE HAS BEEN FOUND EXPERIENCING INABILITY TO CONTAIN MEDICATION DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THE BODY OF THE SYRINGE HAS HAIRLINE CRACKS.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE BD DISCARDIT¿ II SYRINGE W/O NEEDLE HAS BEEN FOUND EXPERIENCING INABILITY TO CONTAIN MEDICATION DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THE BODY OF THE SYRINGE HAS HAIRLINE CRACKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907865 BD DISCARDIT II SYRINGE W/O NEEDLE SYRINGE FMF BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other