BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML BD LUER-LOK LUER-LOK TIP

    MDR report key: 10480493 · Received September 1, 2020

    Report

    Report Number
    1213809-2020-00589
    Event Type
    Malfunction
    Date Received
    September 1, 2020
    Date of Event
    August 9, 2020
    Report Date
    September 9, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: FOUR 3ML SYRINGES IN FULLY SEALED BLISTER PACKS CONFIRMED TO BE FROM BATCH 0150246 (P/N 309657) WERE RECEIVED AND EVALUATED. IT WAS OBSERVED ALL FOUR OF THE SYRINGES HAD NO SCALE MARKINGS ON THE BARREL, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE MISSING SCALE MARKING DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 0150246 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. 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 H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 50 3 ML BD LUER-LOK¿ LUER-LOK¿ TIPS EXPERIENCED SCALE MARKING ISSUES WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT CATALOG NUMBER: 309657. PRODUCT DESCRIPTION: SYRINGE 3ML LF STRL GRAD N-PYRG LL DEHP-FR PVC FREE MED DISP ORIGIN OF THE ISSUE: NURSING/DETAIL: NO ML LINES ON SYRINGE./NUMBER OF OCCURRENCES: 50.0/SAMPLE AVAILABLE: TRUE/LOT NUMBER: 0150246.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER OCCUPATION: MEMBER SUPPORT ANALYST, MEMBER OPERATIONS, MATERIALS MANAGEMENT A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 50 3 ML BD LUER-LOK¿ LUER-LOK¿ TIPS EXPERIENCED SCALE MARKING ISSUES WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT CATALOG NUMBER: 309657. PRODUCT DESCRIPTION: SYRINGE 3ML LF STRL GRAD N-PYRG LL DEHP-FR PVC FREE MED DISP ORIGIN OF THE ISSUE: NURSING/DETAIL: NO ML LINES ON SYRINGE./NUMBER OF OCCURRENCES: 50.0/SAMPLE AVAILABLE: TRUE/LOT NUMBER: 0150246.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945093 3 ML BD LUER-LOK LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309657 0150246 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other