BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML LS EMERALD

    MDR report key: 8729254 · Received June 24, 2019

    Report

    Report Number
    3002682307-2019-00378
    Event Type
    Malfunction
    Date Received
    June 24, 2019
    Date of Event
    June 6, 2019
    Report Date
    August 1, 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
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAS NOT BEEN PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 307731 LOT 1811198 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 TIP OF THE BARREL. BASED ON THIS FACT, BD BELIEVES THAT THE SYRINGE TIP COULD BREAK BECAUSE OF THE STRONG CONDITIONS DURING USE 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. BD CAN ENSURE THAT THE PROBABILITY OF FINDING THIS KIND OF DEFECT IS ISOLATED AND ANY RECURRENCE IS REALLY UNLIKELY IN OUR PRODUCTS SINCE REVIEW SYRINGE DHR 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 ACTIONS ARE REQUIRED. H3 OTHER TEXT : SEE SECTION H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 5ML LS EMERALD EXPERIENCED THE TIP/LUER OF SYRINGE BREAKING OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WANTED TO REPORT THAT WHILE USING THE BD 5ML LURE TIP SYRINGE TO DELIVER MEDICATION INTO AN ACCESS PORT OF AN IV GIVING SET BY ANOTHER COMPANY, THE TIP OF THE SYRINGE SNAPPED OFF AND BECAME STUCK INSIDE THE PORT. LOT 1811198 IT WAS A BLUE BUNG ACCESS PORT THAT CAME INTEGRATED WITH A NORMAL PERIPHERAL IV GIVING SET.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 AN UNSPECIFIED NUMBER OF SYRINGE 5ML LS EMERALD EXPERIENCED THE TIP/LUER OF SYRINGE BREAKING OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WANTED TO REPORT THAT WHILE USING THE BD 5ML LURE TIP SYRINGE TO DELIVER MEDICATION INTO AN ACCESS PORT OF AN IV GIVING SET BY ANOTHER COMPANY, THE TIP OF THE SYRINGE SNAPPED OFF AND BECAME STUCK INSIDE THE PORT. LOT 1811198. IT WAS A BLUE BUNG ACCESS PORT THAT CAME INTEGRATED WITH A NORMAL PERIPHERAL IV GIVING SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522729 SYRINGE 5ML LS EMERALD SYRINGE FMF BECTON DICKINSON, S.A. 1811198

    Patients

    Seq Age Sex Outcome Treatment
    1 Other