BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5 ML BD LUER-LOK SYRINGE STERILE, SINGLE USE

    MDR report key: 10388781 · Received August 10, 2020

    Report

    Report Number
    1213809-2020-00520
    Event Type
    Malfunction
    Date Received
    August 10, 2020
    Date of Event
    July 11, 2020
    Report Date
    August 24, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096467
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 8/10/2020. H.6. INVESTIGATION: AN UNKNOWN NUMBER OF REPORTEDLY USED 5ML SAMPLES, CONTAMINATED WITH UNKNOWN MEDICATION, WERE RECEIVED. DUE TO CONTAINING UNKNOWN MEDICATION OR MEDICATION RESIDUE, THE SAMPLES COULD NOT BE HANDLED FOR EVALUATION AND THE DEFECTS COULD NOT BE CONFIRMED. NO PHOTOS WERE RECEIVED TO CONFIRM THE DEFECT VIA A PHOTO SAMPLE. A NON-CONTAMINATED SAMPLE OR A PHOTO IS REQUIRED FOR EVALUATION BY THE MANUFACTURING SITE. SINCE NO SAMPLES WERE RECEIVED FOR EVALUATION NO DEFECTS COULD BE CONFIRMED OR NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. DHR WAS PERFORMED. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 5 ML BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE EXPERIENCED A FAILURE TO CONTAIN BLOOD/MEDICATION PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309646 BATCH NO: 0080722 COMPLAINT 2 OF 2. ORIGINALLY ONE BD 5ML SYRINGE WAS FOUND TO HAVE CRACKS. THESE OCCURRENCES HAPPENED ON 2 SEPARATE DAYS. WE HAVE THE 5ML SYRINGE IN OUR POSSESSION. A COUPLE DAYS LATER, ANOTHER DEFECTIVE BD 5ML SYRINGE WAS NOTED BEFORE IT WAS SENT OFF. BD 5ML LOT #: 0080722 BD 5ML REF: (B)(4).

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 5 ML BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE EXPERIENCED A FAILURE TO CONTAIN BLOOD/MEDICATION PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309646 BATCH NO: 0080722 COMPLAINT 2 OF 2. ORIGINALLY ONE BD 5ML SYRINGE WAS FOUND TO HAVE CRACKS. THESE OCCURRENCES HAPPENED ON 2 SEPARATE DAYS. WE HAVE THE 5ML SYRINGE IN OUR POSSESSION. A COUPLE DAYS LATER, ANOTHER DEFECTIVE BD 5ML SYRINGE WAS NOTED BEFORE IT WAS SENT OFF. BD 5ML LOT #: 0080722 BD 5ML REF: 309646

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853227 5 ML BD LUER-LOK SYRINGE STERILE, SINGLE USE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309646 0080722 30382903096467

    Patients

    Seq Age Sex Outcome Treatment
    1 Other