BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD EMERALD¿ SYRINGE

    MDR report key: 7659574 · Received July 3, 2018

    Report

    Report Number
    3002682307-2018-00157
    Event Type
    Injury
    Date Received
    July 3, 2018
    Date of Event
    June 14, 2018
    Report Date
    August 14, 2018
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: SEX: FEMALE, EVENT ATTRIBUTED TO: REQUIRED INTERVENTION, DEVICE SINGLE USE?: NO, DEVICE RETURNED TO MANUFACTURE: NO.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THREE REFERENCE SAMPLES WERE RETURNED IN SUPPORT OF THIS COMPLAINT. THE INSPECTION OF THESE RETURNED SAMPLES DID NOT PRESENT ANY ISSUES OR DEFECTS. UNFORTUNATELY, THE REPORTED ISSUE WAS NOT ABLE TO BE VERIFIED. IT IS BELIEVED THAT THE SYRINGE TIP COULD BREAK BECAUSE OF ANY IMPERCEPTIBLE DAMAGE IN THE BARREL AT THE MOMENT OF USE OR SOME STRONG CONDITION DURING HANDLING. DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT. INVESTIGATION CONCLUSION: NOT ABLE TO CONFIRM THE REPORTED ISSUE. POSSIBLE MINOR DAMAGED IN THE BARREL WHICH PRODUCED BREAKAGE OF THE TIP DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE "LUER SLIP ADAPTER BROKE" ON A 10 ML BD EMERALD¿ SYRINGE WHILE TAKING BLOOD FROM A PATIENT RESULTING IN BLOOD SPLASHING ONTO A NURSE'S FACE. THE NURSE CONTACTED OCCUPATIONAL HEALTH AND WAS ADVISED "NO BLOODS NEEDED TO BE TAKEN." THERE WAS NO ADDITIONAL MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE "LUER SLIP ADAPTER BROKE" ON A 10 ML BD EMERALD¿ SYRINGE WHILE TAKING BLOOD FROM A PATIENT RESULTING IN BLOOD SPLASHING ONTO A NURSE'S FACE. THE NURSE CONTACTED OCCUPATIONAL HEALTH AND WAS ADVISED "NO BLOODS NEEDED TO BE TAKEN." THERE WAS NO ADDITIONAL MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. (B)(6). THREE POTENTIAL LOT NUMBERS WERE PROVIDED FOR THIS INCIDENT. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS:  MEDICAL DEVICE LOT #: 1709373, MEDICAL DEVICE EXPIRATION DATE: 2022-08-31, DEVICE MANUFACTURE DATE: 2017-09-21, MEDICAL DEVICE LOT #: 1702394, MEDICAL DEVICE EXPIRATION DATE: 2022-01-31, DEVICE MANUFACTURE DATE: 2017-02-13, MEDICAL DEVICE LOT #: 1801388, MEDICAL DEVICE EXPIRATION DATE: 2022-12-31, DEVICE MANUFACTURE DATE: 2018-01-30. (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 THE "LUER SLIP ADAPTER BROKE" ON A 10 ML BD EMERALD¿ SYRINGE WHILE TAKING BLOOD FROM A PATIENT RESULTING IN BLOOD SPLASHING ONTO A NURSE'S FACE. THE NURSE CONTACTED OCCUPATIONAL HEALTH AND WAS ADVISED "NO BLOODS NEEDED TO BE TAKEN." THERE WAS NO ADDITIONAL MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502037 BD EMERALD¿ SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention