BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ DISPOSABLE SYRINGE

    MDR report key: 7655950 · Received July 2, 2018

    Report

    Report Number
    1213809-2018-00391
    Event Type
    Malfunction
    Date Received
    July 2, 2018
    Date of Event
    June 8, 2018
    Report Date
    September 11, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE SEALED, ONE OPEN PACKAGED 1ML SYRINGES AND 3 EMPTY PACKAGES WERE RECEIVED AND CONFIRMED TO BE FROM BATCH #8001745 (P/N 309628). THE SEALED SYRINGE AND 3 EMPTY PACKAGES HAD NO VISUAL DEFECTS. THE SYRINGE FROM THE OPEN PACKAGE HAD BROWN FOREIGN MATTER FROM THE BARREL FLANGE TO APPROXIMATELY THE 0.5 GRAD LINE. THIS FOREIGN MATTER IS DEGRADED PLASTIC FROM THE MOLDING PROCESS. THE BURNT BARREL OBSERVED IS REJECTABLE PER PRODUCT SPECIFICATION. THE POTENTIAL ROOT CAUSE FOR THE BURNT BARREL DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. INVESTIGATION CONCLUSION: THE POTENTIAL ROOT CAUSE FOR THE BURNT BARREL DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS.

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: DEVICE RETURNED TO MANUFACTURE: YES.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD LUER-LOK¿ DISPOSABLE SYRINGE THERE WAS AN ISSUE WITH FOREIGN MATTER. IT WAS STATED "THE SYRINGE WAS OBSERVED IN POOR CONDITION. THE PACKAGING WASN'T OPENED AND THE SYRINGE APPEARED DIRTY AND/OR BURNED." THERE WAS NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD LUER-LOK DISPOSABLE SYRINGE THERE WAS AN ISSUE WITH FOREIGN MATTER. IT WAS STATED "THE SYRINGE WAS OBSERVED IN POOR CONDITION. THE PACKAGING WASN'T OPENED AND THE SYRINGE APPEARED DIRTY AND/OR BURNED." THERE WAS NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 WITH THE USE OF THE BD LUER-LOK¿ DISPOSABLE SYRINGE THERE WAS AN ISSUE WITH FOREIGN MATTER. IT WAS STATED "THE SYRINGE WAS OBSERVED IN POOR CONDITION. THE PACKAGING WASN'T OPENED AND THE SYRINGE APPEARED DIRTY AND/OR BURNED." THERE WAS NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499293 BD LUER-LOK¿ DISPOSABLE SYRINGE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8001745 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other