BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 10ML SYRINGE LUER-LOK TIP

    MDR report key: 8744211 · Received June 28, 2019

    Report

    Report Number
    1213809-2019-00676
    Event Type
    Malfunction
    Date Received
    June 28, 2019
    Date of Event
    June 7, 2019
    Report Date
    August 9, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096047
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO OF A LOOSE 10ML SYRINGE WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THE SYRINGE IN THE PHOTO HAD A SKEWED SCALE AND WAS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE SKEWED SCALE DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. 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 H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SCALE MARKING ISSUES WERE FOUND BEFORE USE WITH A BD 10ML SYRINGE LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "PER EMAIL: I'M EMAILING TO REPORT A PRODUCT QUALITY ISSUE REGARDING TWO 10 ML BD SYRINGES. THE MARKINGS WERE PRINTED IN A SLANTED MANNER WHICH RESULTED IN POTENTIALLY INACCURATE DOSING." 2 OCCURRENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    PMA / 510(K)#: K980987, K151766. 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 THAT SCALE MARKING ISSUES WERE FOUND BEFORE USE WITH A BD 10ML SYRINGE LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "PER EMAIL: I'M EMAILING TO REPORT A PRODUCT QUALITY ISSUE REGARDING TWO 10 ML BD SYRINGES. THE MARKINGS WERE PRINTED IN A SLANTED MANNER WHICH RESULTED IN POTENTIALLY INACCURATE DOSING." 2 OCCURRENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536531 BD 10ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7170519 30382903096047

    Patients

    Seq Age Sex Outcome Treatment
    1 Other