BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL 200 S/C

    MDR report key: 9405609 · Received December 3, 2019

    Report

    Report Number
    9614033-2019-00285
    Event Type
    Malfunction
    Date Received
    December 3, 2019
    Date of Event
    October 6, 2019
    Report Date
    February 3, 2020
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K151766
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES OR PHOTOS DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION. HOWEVER, CORRECTIVE AND PREVENTATIVE ACTION, CAPA#1132752, WAS OPENED TO INVESTIGATE THE REPORTED DEFECT. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE BD¿ SYRINGE 3ML LL 200 S/C HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE SYRINGE LEAKED WHEN ATTACHED AT THE BUFF CAP DURING AN IV INFUSION. NEONATAL INTENSIVE CARE UNIT RN NOTED A 3ML SYRINGE LEAKING WHEN ATTACHED AT THE BUFF CAP DURING AN IV INFUSION. THE INFUSION WAS STOPPED AND A NEW SYRINGE WAS OBTAINED FROM PHARMACY. THERE WAS NO HARM TO THE INFANT. MEDWATCH REPORTS# (B)(4) WERE FILED IN RESPONSE TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    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 HAS BEEN REPORTED THAT ONE BD¿ SYRINGE 3ML LL 200 S/C HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE SYRINGE LEAKED WHEN ATTACHED AT THE BUFF CAP DURING AN IV INFUSION. NEONATAL INTENSIVE CARE UNIT RN NOTED A 3ML SYRINGE LEAKING WHEN ATTACHED AT THE BUFF CAP DURING AN IV INFUSION. THE INFUSION WAS STOPPED AND A NEW SYRINGE WAS OBTAINED FROM PHARMACY. THERE WAS NO HARM TO THE INFANT. MEDWATCH REPORTS# (B)(4) WERE FILED IN RESPONSE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201628 BD SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 309657 8330522 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other