BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 8713112 · Received June 19, 2019

    Report

    Report Number
    3003152976-2019-00405
    Event Type
    Malfunction
    Date Received
    June 19, 2019
    Date of Event
    May 17, 2019
    Report Date
    September 30, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS NOT REPORTABLE UPON FURTHER REVIEW. THE SAMPLES RETURNED SHOWED THAT FOREIGN MATTER WAS VISIBLE ON THE OUTSIDE OF THE PRODUCT. THIS IS NOT MDR REPORTABLE. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. FOREIGN MATTER NOT WITHIN THE FLUID PATHWAY MAY CAUSE A CUSTOMER INCONVENIENCE BUT WILL NOT LEAD TO ANY DEGREE OF HARM/SERIOUS INJURY. THE REPORT#: 3003152976-2019-00405 IS NULL AND VOID AS IT IS NOT LONGER MDR REPORTABLE.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: TEN PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. IN ALL PHOTOS, BLACK SPOTS CAN BE OBSERVED ON THE PLUNGER NERVES OR WITHIN THE BLISTER PACK. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOTS 1902257,1901240, AND1903215, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THE REPORTED ISSUE WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. WITHOUT A PHYSICAL SAMPLE WE COULD NOT CONDUCT CHARACTERIZATION ANALYSIS ON THE FOREIGN MATTER TO FURTHER IDENTIFY THE ORIGIN. BASED ON THE PHOTO AND AVAILABLE INFORMATION, WE ARE NOT ABLE TO DETERMINED A ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED FOR FUTURE OCCURRENCE. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLACK PARTICLES WERE FOUND IN THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE BEFORE USE. LOT#'S 1902257, 1901240, AND 1903215 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: HERE ARE SOME REPRESENTATIVE PHOTOS OF THE BLACK PARTICLES OBSERVED ON LOTS: 1902257, 1901240, 1903215 SYRINGES OF 60ML.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLACK PARTICLES WERE FOUND IN THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE BEFORE USE. LOT #'S 1902257, 1901240, AND 1903215 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: HERE ARE SOME REPRESENTATIVE PHOTOS OF THE BLACK PARTICLES OBSERVED ON LOTS 1902257, 1901240, 1903215 SYRINGES OF 60ML.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1902257, MEDICAL DEVICE EXPIRATION DATE: 2024-01-31, DEVICE MANUFACTURE DATE: 2019-02-25. MEDICAL DEVICE LOT #: 1901240, MEDICAL DEVICE EXPIRATION DATE: 2023-12-31, DEVICE MANUFACTURE DATE: 2019-01-24. MEDICAL DEVICE LOT #: 1903215, MEDICAL DEVICE EXPIRATION DATE: 2024-02-29, DEVICE MANUFACTURE DATE:2019-03-21. 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 BLACK PARTICLES WERE FOUND IN THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE BEFORE USE. LOT #'S 1902257, 1901240, AND 1903215 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: HERE ARE SOME REPRESENTATIVE PHOTOS OF THE BLACK PARTICLES OBSERVED ON LOTS 1902257, 1901240, 1903215 SYRINGES OF 60ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508397 BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other