BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 3ML SYRINGE W/ LUER-LOK¿ TIP WITH VIAL ACCESS CANNULA

    MDR report key: 8769117 · Received July 8, 2019

    Report

    Report Number
    1213809-2019-00711
    Event Type
    Malfunction
    Date Received
    July 8, 2019
    Date of Event
    June 21, 2019
    Report Date
    August 12, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903034018
    PMA / PMN Number
    K924439
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: FIVE 3ML SYRINGES WITH NEEDLE IN BLISTER PACKS FROM BATCH 9060931 (P/N 303401) WERE RECEIVED AND EVALUATED. IT WAS OBSERVED ONE OF THE PACKAGES WAS OPENED AND FOUR WERE FULLY SEALED. THE SYRINGE IN THE OPENED PACKAGE APPEARED TO HAVE AN INSECURE STOPPER CONDITION WHERE THE STOPPER WAS NOT FULLY SEATED ON THE END OF THE PLUNGER ROD AND WAS REJECTABLE PER PRODUCT SPECIFICATION. THE OTHER FOUR SAMPLES HAD NO VISUAL DEFECTS. 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. POTENTIAL ROOT CAUSE FOR THE INSECURE STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. MOST LIKELY THERE WAS A MISALIGNMENT BETWEEN THE PLUNGER ROD AND STOPPER DIAL. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 9060931 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD 3ML SYRINGE W/ LUER-LOK¿ TIP WITH VIAL ACCESS CANNULA PLUNGER ROD WAS DAMAGED AND LEAKED. THIS WAS DISCOVERED DURING USE. NO DATE/TIME OR PATIENT INFORMATION WAS GIVEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 303401 BATCH NO: 9060931. IT WAS REPORTED THAT PLUNGER IS NOT FLUSH INSIDE THE BARREL, CAUSING THE SYRINGE TO LEAK. PER CUSTOMER EMAIL: THERE SEEMS TO BE AN ISSUE WITH THE BD 3ML SYRINGE REF # 303401 (P/S 27638). PUT IN A SAFETY NET COMPLAINING THAT THE MEDICATION IS LEAKING OUT OF THE SYRINGE ON A FEW OCCASIONS. AFTER PHYSICALLY LOOKING AT THE SYRINGE SHE HANDED ME, I NOTICED THAT THE PLUNGER IS NOT FLUSH INSIDE THE BARREL.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 W/ LUER-LOK¿ TIP WITH VIAL ACCESS CANNULA PLUNGER ROD WAS DAMAGED AND LEAKED. THIS WAS DISCOVERED DURING USE. NO DATE/TIME OR PATIENT INFORMATION WAS GIVEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 303401, BATCH NO: 9060931. IT WAS REPORTED THAT PLUNGER IS NOT FLUSH INSIDE THE BARREL, CAUSING THE SYRINGE TO LEAK. PER CUSTOMER EMAIL: THERE SEEMS TO BE AN ISSUE WITH THE BD 3ML SYRINGE REF # 303401 (P/S 27638). PUT IN A SAFETY NET COMPLAINING THAT THE MEDICATION IS LEAKING OUT OF THE SYRINGE ON A FEW OCCASIONS. AFTER PHYSICALLY LOOKING AT THE SYRINGE SHE HANDED ME, I NOTICED THAT THE PLUNGER IS NOT FLUSH INSIDE THE BARREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559946 BD 3ML SYRINGE W/ LUER-LOK¿ TIP WITH VIAL ACCESS CANNULA HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 9060931 30382903034018

    Patients

    Seq Age Sex Outcome Treatment
    1 Other