BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK TIP

    MDR report key: 9070198 · Received September 16, 2019

    Report

    Report Number
    1213809-2019-00929
    Event Type
    Malfunction
    Date Received
    September 16, 2019
    Date of Event
    August 28, 2019
    Report Date
    September 27, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE 1ML SYRINGE IN AN OPENED BLISTER PACK FROM BATCH 9112904 (P/N 309628) WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THE STOPPER WAS NOT CONNECTED TO THE PLUNGER ROD AND WAS REJECTABLE PER PRODUCT SPECIFICATION. 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 STOPPER SEPARATION DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS.

    Description of Event or Problem · 0

    MATERIAL NO.: 309628. BATCH: 9112904. IT WAS REPORTED THAT BEFORE USE OF THE BD SYRINGE LUER-LOK¿ TIP THERE WAS STOPPER SEPARATION FROM PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE WAS STOPPER SEPARATION FROM PLUNGER.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    MATERIAL NO.: 309628. BATCH: 9112904. IT WAS REPORTED THAT BEFORE USE OF THE BD SYRINGE LUER-LOK¿ TIP THERE WAS STOPPER SEPARATION FROM PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE WAS STOPPER SEPARATION FROM PLUNGER..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866842 BD SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9112904 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other