BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 1ML SYRINGE LUER-LOK TIP

    MDR report key: 10365497 · Received August 4, 2020

    Report

    Report Number
    1213809-2020-00507
    Event Type
    Malfunction
    Date Received
    August 4, 2020
    Date of Event
    July 10, 2020
    Report Date
    September 1, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVALUATION?: YES. D.10. RETURNED TO MANUFACTURER ON: (B)(6) 2020. H.6. INVESTIGATION: THREE PHOTOS AND 15 LOOSE 1ML LL SYRINGES, AS WELL AS FOUR PACKAGES, CONFIRMED TO BE FROM BATCH # 9232833 (P/N (B)(6)), WERE RECEIVED. THE SAMPLES WERE VISUALLY EVALUATED. THE SYRINGES WERE OBSERVED TO HAVE A SINGLE SCRATCH ON THEIR BARREL WALLS NEXT TO APPROXIMATELY 0.15ML GRAD LINE OUTSIDE THE SCALE MARKINGS. THE SCRATCH WAS SUPERFICIAL AND CONSIDERED TO BE A COSMETIC DEFECT NOT AFFECTING FIT, FORM, OR FUNCTION OF THE PRODUCT, AND THEREFORE ACCEPTABLE PER PRODUCT SPECIFICATION. A POTENTIAL ROOT CAUSE FOR THE SCRATCH MARKS IS ASSOCIATED WITH THE MARKING PROCESS. SINCE THE DEFECTS OBSERVED ARE WITHIN THE ACCEPTABLE LIMITS, NO CORRECTIVE ACTIONS ARE NECESSARY AT THIS TIME. DHR WAS PERFORMED. THIS REVIEW DETERMINED THAT ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET AND THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD 1ML SYRINGE LUER-LOK¿ TIP HAD SCRATCHES IN IT. THIS OCCURRED ON 15 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SCRATCHES IN SYRINGE PLASTIC.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD 1 ML SYRINGE LUER-LOK¿ TIP HAD SCRATCHES IN IT. THIS OCCURRED ON 15 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SCRATCHES IN SYRINGE PLASTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827806 BD 1ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309628 9232833 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other