BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK TIP

    MDR report key: 9950576 · Received April 10, 2020

    Report

    Report Number
    1213809-2020-00245
    Event Type
    Malfunction
    Date Received
    April 10, 2020
    Date of Event
    March 20, 2020
    Report Date
    March 26, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096498
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THREE PHOTOS DISPLAYING LOOSE 5ML SYRINGES WERE RECEIVED AND EVALUATED. TWO PHOTOS DISPLAYED THE TOP VIEW OF A BLISTER PACK FROM BATCH 9200384 (P/N 309649) NEXT TO A SYRINGE WITH A SINGLE LENGTHWISE BLACK STRIPE EXTENDING HALFWAY UP THE BARREL. ONE PHOTO DISPLAYED A SYRINGE WITH MULTIPLE FIBER-LIKE INK SPOTS SCATTERED IN THE MIDDLE OF THE BARREL. BOTH SYRINGES IN THE PHOTOS WERE 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. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, BATCH 9200384 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. INVESTIGATION CONCLUSION: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE WITH THE SAMPLE PROVIDED. ROOT CAUSE DESCRIPTION: POTENTIAL ROOT CAUSE FOR THE MISSING PRINT AND INK SPOTS DEFECTS ARE ASSOCIATED WITH THE MARKING PROCESS. RATIONALE: NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD SYRINGE LUER-LOK¿ TIP WAS FOUND WITHOUT SCALE MARKINGS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING THE FILLING OF A TRANSPARENT GEL ON 20.03.2020 IT WAS FOUND THAT SOME 5ML-BD (APPROX. 10 SYRINGES OUT OF 100) WITH THE BATCH LOT 9200384 SHOWED CLEAR DEFECTS IN THE EXTERNAL PRINTING. AFTER FILLING THE SYRINGES AN "UNAESTHETIC" APPEARANCE APPEARED, AT FIRST IT LOOKED AS IF IT WAS IN GEL BLACK, CRIMPED MACRO FUZZY. ALTHOUGH THERE IS NO DANGER FOR THE USER/PATIENT, THE DOSAGE OF THE PREPARATION IN THIS FORM IS NOT APPROPRIATE"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411093 BD SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309649 9200384 30382903096498

    Patients

    Seq Age Sex Outcome Treatment
    1 Other