BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD 5ML SYRINGE

    MDR report key: 9142473 · Received October 1, 2019

    Report

    Report Number
    3002682307-2019-00529
    Event Type
    Malfunction
    Date Received
    October 1, 2019
    Date of Event
    September 11, 2019
    Report Date
    October 23, 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
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAS BEEN PROVIDED WITH A SAMPLE FOR CATALOG 307731 LOT 1810147 TO INVESTIGATE FOR THIS RECORD. VISUAL INSPECTION OF THE RETURNED SAMPLE PRESENTED THE TIP BROKEN. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. THE MATERIAL USED TO MANUFACTURE EMERALD 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 TIP OF THE BARREL. BASED ON THIS FACT, BD BELIEVES THAT THE SYRINGE TIP COULD BREAK BECAUSE OF AN IMPERCEPTIBLE DAMAGE IN THE BARREL TIP AT THE TIME OF USE OR SOME STRONG CONDITION DURING TRANSPORT OF THE PRODUCT. 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. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BREAKAGE OCCURRED DURING USE WITH A BD EMERALD¿ 5ML SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE NURSE, WAS GOING TO CUFF THE GASTRO-TUBE. THEY ASPIRE EVERY 3 WEEKS. SHE PUT THE BD EMERALD SYRINGE IN THE ¿ENTRANCE¿ / ¿INJECTION PORT¿ AND SHOULD START TO ASPIRE WHEN THE SYRINGE TIP GOT OFF / BROKE. NO FORCE AT ALL (SHE HAS DONE THIS SEVERAL TIMES BEFORE). SHE COULD TAKE THE SYRINGE TIP OUT FROM THE ¿ENTRANCE¿ / ¿INJECTION PORT¿, WITH A PINCETTE / TWEEZER. AFTER THEY GOT THE TIP OUT THEY TOOK ANOTHER BD EMERALD, FROM THE SAME PACKAGE / LOT-NUMBER, AND EVERYTHING WORKED FINE. IT HAS NOT HAPPENED BEFORE OR AFTER."

    Additional Manufacturer Narrative · 1

    (B)(6). 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 · 1

    IT WAS REPORTED THAT BREAKAGE OCCURRED DURING USE WITH A BD EMERALD¿ 5ML SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE NURSE, WAS GOING TO CUFF THE GASTRO-TUBE. THEY ASPIRE EVERY 3 WEEKS. SHE PUT THE BD EMERALD SYRINGE IN THE ¿ENTRANCE¿ / ¿INJECTION PORT¿ AND SHOULD START TO ASPIRE WHEN THE SYRINGE TIP GOT OFF / BROKE. NO FORCE AT ALL (SHE HAS DONE THIS SEVERAL TIMES BEFORE). SHE COULD TAKE THE SYRINGE TIP OUT FROM THE ¿ENTRANCE¿ / ¿INJECTION PORT¿, WITH A PINCETTE / TWEEZER. AFTER THEY GOT THE TIP OUT THEY TOOK ANOTHER BD EMERALD, FROM THE SAME PACKAGE / LOT-NUMBER, AND EVERYTHING WORKED FINE. IT HAS NOT HAPPENED BEFORE OR AFTER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937286 BD EMERALD 5ML SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1810147

    Patients

    Seq Age Sex Outcome Treatment
    1 Other