BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 3ML SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE

    MDR report key: 9395517 · Received December 2, 2019

    Report

    Report Number
    1213809-2019-01194
    Event Type
    Malfunction
    Date Received
    December 2, 2019
    Date of Event
    November 15, 2019
    Report Date
    January 6, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095729
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, SO 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 SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD 3ML SYRINGE LUER-LOK¿ TIP WITH BD PRECISIONGLIDE¿ NEEDLE HAD MOLD ON IT. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309572 BATCH NO. 9203066 IT WAS REPORTED THAT MOLD WAS NOTICED ON LUER LOK SYRINGES WHEN DISPENSING THE SYRINGES TO A CONSUMER. PHARMACIST CALLED TO REPORT MOLD ON LUER LOK SYRINGES (1) FULL BOX OF INDIVIDUALLY WRAPPED SYRINGES. STATED THAT SHE WAS DISPENSING THE SYRINGES TO A CONSUMER WHEN SHE NOTICED THE MOLD.

    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 WAS REPORTED THAT BD 3ML SYRINGE LUER-LOK¿ TIP WITH BD PRECISIONGLIDE¿ NEEDLE HAD MOLD ON IT. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309572 BATCH NO. 9203066. IT WAS REPORTED THAT MOLD WAS NOTICED ON LUER LOK SYRINGES WHEN DISPENSING THE SYRINGES TO A CONSUMER. PHARMACIST CALLED TO REPORT MOLD ON LUER LOK SYRINGES (1) FULL BOX OF INDIVIDUALLY WRAPPED SYRINGES. STATED THAT SHE WAS DISPENSING THE SYRINGES TO A CONSUMER WHEN SHE NOTICED THE MOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1193807 BD 3ML SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309572 9203066 30382903095729

    Patients

    Seq Age Sex Outcome Treatment
    1 Other