BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 1ML SYRINGE LUER-LOK TIP

    MDR report key: 9261029 · Received October 31, 2019

    Report

    Report Number
    1213809-2019-01086
    Event Type
    Malfunction
    Date Received
    October 31, 2019
    Date of Event
    October 16, 2019
    Report Date
    November 14, 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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: FOUR PHOTOS DISPLAYING A TOTAL OF TWO 1ML SYRINGES IN FULLY SEALED BLISTER PACKS FROM BATCH 9112902 (P/N 309628) WERE RECEIVED AND EVALUATED. IT WAS OBSERVED ONE OF THE SYRINGES CONTAINED A BENT FLANGE AND A SCALE SHIFTED UPWARDS APPROXIMATELY 0.05ML. THE FLANGE DAMAGE AND VOLUMETRIC ACCURACY OF THE SYRINGE WERE REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE VOLUMETRIC ACCURACY DEFECT IS ASSOCIATED WITH THE PRINTING PROCESS. IT IS LIKELY THE BARREL FEEDING ISSUES CAUSED THE BENT FLANGE. FROM THE UPWARDS BENT FLANGE, THE SYRINGE BARREL WAS UNABLE TO SIT FLUSH AGAINST THE BACKSTOP WHICH RESULTED IN THE BARREL BEING SHIFTED SLIGHTLY DOWNWARD WHEN GOING THROUGH THE MARKER. A BENT FLANGE REJECTION SYSTEM WILL BE IMPLEMENTED TO THIS MACHINE. 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. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD 1ML SYRINGE LUER-LOK¿ TIP HAD SCALE MARKING ISSUES. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A 1ML LUER LOCK SYRINGE WITH THE INCORRECT MARKINGS. THERE IS AN APPROXIMATE 0.5ML GAP AT THE TOP OF THE SYRINGE WHERE THE MARKINGS SHOULD BEGIN. THIS IS AN OBVIOUS SAFETY ISSUE. THANKFULLY, THE NURSE IDENTIFIED THIS ISSUE BEFORE ANY MEDICATION WAS GIVEN TO THE PATIENT. AND FOR THIS REASON NO HARM CAME TO THE PATIENT. ALL OTHER SYRINGES OF THIS BATCH NUMBER WITHIN THIS WARD WERE CHECKED ¿ WITH NO IDENTIFIED AFFECTED PRODUCTS.

    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 1ML SYRINGE LUER-LOK¿ TIP HAD SCALE MARKING ISSUES. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A 1ML LUER LOCK SYRINGE WITH THE INCORRECT MARKINGS. THERE IS AN APPROXIMATE 0.5ML GAP AT THE TOP OF THE SYRINGE WHERE THE MARKINGS SHOULD BEGIN. THIS IS AN OBVIOUS SAFETY ISSUE. THANKFULLY, THE NURSE IDENTIFIED THIS ISSUE BEFORE ANY MEDICATION WAS GIVEN TO THE PATIENT. AND FOR THIS REASON NO HARM CAME TO THE PATIENT. ALL OTHER SYRINGES OF THIS BATCH NUMBER WITHIN THIS WARD WERE CHECKED ¿ WITH NO IDENTIFIED AFFECTED PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053465 BD 1ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9112902 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other