BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML BD LUER-LOK LUER-LOK TIP

    MDR report key: 10080496 · Received May 21, 2020

    Report

    Report Number
    9614033-2020-00077
    Event Type
    Malfunction
    Date Received
    May 21, 2020
    Date of Event
    April 18, 2020
    Report Date
    June 1, 2020
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K151766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY : SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. HOWEVER A CAPA 1132752 WAS OPENED TO INVESTIGATE. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CALLER REPORTED THE SYRINGE STARTED LEAKING. NUMBER OF OCCURRENCES - 1 DID THE CALLER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? - NO PRODUCT WITH ISSUE - BD 3ML SYRINGE, PN 309657. PRODUCT LOT # - 8345759. DID ISSUE CAUSE ANY INJURY? - NO. DID CUSTOMER REQUIRE MEDICAL INTERVENTION? - NO. IS PRODUCT MANUFACTURED BY BD? - YES, SAMPLE IS NOT AVAILABLE FOR INVESTIGATION. RESOLUTION - CALLER WAS ABLE TO SUCCESSFULLY FILL A CARTRIDGE. NO FURTHER ACTION REQUIRED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER OCCUPATION: (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 THE 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CALLER REPORTED THE SYRINGE STARTED LEAKING. NUMBER OF OCCURRENCES - 1. DID THE CALLER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? - NO. PRODUCT WITH ISSUE - BD 3ML SYRINGE, PN 309657. PRODUCT LOT # - 8345759. DID ISSUE CAUSE ANY INJURY? - NO. DID CUSTOMER REQUIRE MEDICAL INTERVENTION? - NO. IS PRODUCT MANUFACTURED BY BD? - YES, SAMPLE IS NOT AVAILABLE FOR INVESTIGATION. RESOLUTION - CALLER WAS ABLE TO SUCCESSFULLY FILL A CARTRIDGE. NO FURTHER ACTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541691 3 ML BD LUER-LOK LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 309657 8345759 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other