BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK TIP

    MDR report key: 8420417 · Received March 14, 2019

    Report

    Report Number
    1213809-2019-00333
    Event Type
    Malfunction
    Date Received
    March 14, 2019
    Date of Event
    February 9, 2019
    Report Date
    May 1, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: FOUR LOOSE 10ML SYRINGES WITH RED TIP CAPS AND MEDICATION LABELS WERE RECEIVED AND VISUALLY EVALUATED. THREE OF THE SYRINGES CONTAINED 10ML OF CLEAR FLUID AND ONE CONTAINED 5ML OF CLEAR FLUID. NO DEFECTS WERE OBSERVED IN ANY OF THE SAMPLES. ROOT CAUSE NOT DEFINED SINCE DEFECTS WERE NOT CONFIRMED IN SAMPLES RECEIVED. NO CORRECTIVE ACTIONS RECOMMENDED SINCE PRODUCT DEFECT WAS NOT CONFIRMED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TEN BD SYRINGE LUER-LOK¿ TIP CRACKED AT THE BARREL. CUSTOMER¿S VERBATIM: ¿ PER CUSTOMER EMAIL: DEPARTMENT: MATERIALS MANAGEMENT PRODUCT CATALOG NUMBER: N/A , LOT 9001911 PRODUCT DESCRIPTION: BD 10 ML SYRINGES LUER LOK TIP AND NIPPLE TIP SYRINGES ORIGIN OF THE ISSUE: NURSING DETAIL: SYRINGES HAVE CRACKS IN THE CRINGE BARREL. ALSO, SOME SYRINGES HAVE PIECE OF THE SYRINGE BARRELL MISSING WHERE THE CRACKS HAVE BECOME SO BACK THE SYRINGE BROKE. NUMBER OF OCCURRENCES: 10.0 SAMPLE AVAILABLE: TRUE LOT NUMBER: 9001911 ¿

    Additional Manufacturer Narrative · 1

    (B)(6). 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 TEN BD SYRINGE LUER-LOK¿ TIP CRACKED AT THE BARREL. CUSTOMER¿S VERBATIM: ¿PER CUSTOMER EMAIL: DEPARTMENT: MATERIALS MANAGEMENT. PRODUCT CATALOG NUMBER: N/A, LOT 9001911. PRODUCT DESCRIPTION: BD 10 ML SYRINGES LUER LOK TIP AND NIPPLE TIP SYRINGES. ORIGIN OF THE ISSUE: NURSING. DETAIL: SYRINGES HAVE CRACKS IN THE CRINGE BARREL. ALSO, SOME SYRINGES HAVE PIECE OF THE SYRINGE BARRELL MISSING WHERE THE CRACKS HAVE BECOME SO BACK THE SYRINGE BROKE. NUMBER OF OCCURRENCES: 10.0. SAMPLE AVAILABLE: TRUE. LOT NUMBER: 9001911."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216277 BD SYRINGE LUER-LOK TIP SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9001911 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 Other