BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 20ML SYRINGE

    MDR report key: 8926761 · Received August 23, 2019

    Report

    Report Number
    3003152976-2019-00582
    Event Type
    Malfunction
    Date Received
    August 23, 2019
    Date of Event
    August 8, 2019
    Report Date
    September 19, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903006137
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOTS 1903307 AND 1812291, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF EACH LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, NO FOREIGN MATTER WAS OBSERVED IN ANY OF THE SYRINGES OR BLISTER PACKAGING. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ 20ML SYRINGE HAD FOREIGN MATTER INSIDE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED A COMPLAINT IN RELATION TO PRODUCT BD300613 LOT NUMBER 1903307 & 1812291. THE CUSTOMER STATES THAT WHITE BITS WERE OBSERVED INSIDE THE SYRINGE. I HAVE REQUESTED SAMPLES FROM THE CUSTOMER AND I SHALL FORWARD THESE ON AS SOON AS THEY ARE AVAILABLE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1903307. MEDICAL DEVICE EXPIRATION DATE: 2024-02-29. DEVICE MANUFACTURE DATE: 2019-03-19. MEDICAL DEVICE LOT #: 1812291. MEDICAL DEVICE EXPIRATION DATE: 2023-11-30. DEVICE MANUFACTURE DATE: 2019-01-02. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PLASTIPAK¿ 20ML SYRINGE HAD FOREIGN MATTER INSIDE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED A COMPLAINT IN RELATION TO PRODUCT BD300613 LOT NUMBER 1903307 & 1812291. THE CUSTOMER STATES THAT WHITE BITS WERE OBSERVED INSIDE THE SYRINGE. I HAVE REQUESTED SAMPLES FROM THE CUSTOMER AND I SHALL FORWARD THESE ON AS SOON AS THEY ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722057 BD PLASTIPAK 20ML SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10 00382903006137

    Patients

    Seq Age Sex Outcome Treatment
    1 Other