BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTERLINK¿ BLUNT PLASTIC CANNULA

    MDR report key: 7901404 · Received September 24, 2018

    Report

    Report Number
    1911916-2018-00532
    Event Type
    Malfunction
    Date Received
    September 24, 2018
    Date of Event
    September 4, 2018
    Report Date
    November 12, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903033455
    PMA / PMN Number
    K974363
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TWO-HUNDRED SAMPLES WERE RETURNED IN THEIR ORIGINAL, UNOPENED PACKAGING. THE DEFECT COULD NOT BE CONFIRMED AS REPORTED. IF THE BLUNT PLASTIC CANNULA IS BEING USED TO ACCESS A VIAL, IT MAY DAMAGE THE PART AS THEY ARE DESIGNED FOR USE WITH A SPLIT SEPTUM, AND NOT A VIAL. 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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED. BATCH: 7023880, ASSEMBLY BATCH: 7024992 HAD 83 VISUAL INSPECTIONS PERFORMED ON 4,150 PARTS WITH ZERO DEFECTS NOTED. BATCH: 7111920, ASSEMBLY BATCH: 7060928 HAD 103 VISUAL INSPECTIONS PERFORMED ON 5,150 PARTS WITH ZERO DEFECTS NOTED. BATCH: 7139894, ASSEMBLY BATCH: 7142777 HAD 102 VISUAL INSPECTIONS PERFORMED ON 5,100 PARTS WITH ONE DEFECT NOTED FOR BLACK BURNS ON THE SHIELDS. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCH.

    Additional Manufacturer Narrative · 0

    SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD INTERLINK¿ BLUNT PLASTIC CANNULA WAS BREAKING. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD INTERLINK BLUNT PLASTIC CANNULA WAS BREAKING. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7139894, MEDICAL DEVICE EXPIRATION DATE: 2022-07-31, DEVICE MANUFACTURE DATE: 2017-05-19. MEDICAL DEVICE LOT #: 7111920, MEDICAL DEVICE EXPIRATION DATE: 2022-05-31, DEVICE MANUFACTURE DATE: 2017-04-21. MEDICAL DEVICE LOT #: 7023880, MEDICAL DEVICE EXPIRATION DATE: 2022-03-31, DEVICE MANUFACTURE DATE: 2017-01-23. 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 A BD INTERLINK¿ BLUNT PLASTIC CANNULA WAS BREAKING. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745121 BD INTERLINK¿ BLUNT PLASTIC CANNULA HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10. 30382903033455

    Patients

    Seq Age Sex Outcome Treatment
    1 Other