BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE INTEGRA 3ML W/NDL 25X1 RB

    MDR report key: 9280902 · Received November 5, 2019

    Report

    Report Number
    1213809-2019-01107
    Event Type
    Malfunction
    Date Received
    November 5, 2019
    Date of Event
    October 21, 2019
    Report Date
    November 14, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052708
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. 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 WAS REPORTED THAT THE SYRINGE INTEGRA 3ML W/NDL 25X1 RB EXPERIENCED A CRACKED/DAMAGED/DEFORMED/BENT TIP/LUER WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305270, BATCH NO.: 9093523. REPORTER: PHARMACY. BATCH NUMBER REPORTED: 9093523. PRODUCT DESCRIPTION: BD INTEGRA SYRINGE 3ML 25 GAUGE 1IN INJECTION ISSUE: CRACK IN THE ORANGE SCREW PART THAT CONNECTS SYRINGE TO NEEDLE. PART GAVE WAY DURING FLU SHOT AND ANOTHER ATTEMPT WAS MADE AS VACCINE ENDED UP ON THE WALL AND NOT IN THE PATIENT.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE INTEGRA 3ML W/NDL 25X1 RB EXPERIENCED A CRACKED/DAMAGED/DEFORMED/BENT TIP/LUER WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305270 BATCH NO.: 9093523. REPORTER: PHARMACY. BATCH NUMBER REPORTED: 9093523. PRODUCT DESCRIPTION: BD INTEGRA SYRINGE 3ML 25 GAUGE 1IN INJECTION. ISSUE: CRACK IN THE ORANGE SCREW PART THAT CONNECTS SYRINGE TO NEEDLE. PART GAVE WAY DURING FLU SHOT AND ANOTHER ATTEMPT WAS MADE AS VACCINE ENDED UP ON THE WALL AND NOT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1071085 SYRINGE INTEGRA 3ML W/NDL 25X1 RB PISTON SYRINGE MEG BECTON DICKINSON MEDICAL SYSTEMS 9093523 30382903052708

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other