BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ 1 ML SYRINGES

    MDR report key: 14603619 · Received June 6, 2022

    Report

    Report Number
    3003152976-2022-00252
    Event Type
    Malfunction
    Date Received
    June 6, 2022
    Date of Event
    May 10, 2022
    Report Date
    June 14, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO PHYSICAL SAMPLE WAS PROVIDED OR INVESTIGATION. MULTIPLE PHOTOS WERE PROVIDED WHICH SHOW THE SYRINGE CONNECTED TO A NEEDLE, THERE IS LIQUID OBSERVED WHICH SUGGESTS A LEAKAGE, HOWEVER, THERE IS NO DAMAGE OR OTHER DEFECTS IDENTIFIED THAT COULD HAVE CONTRIBUTED TO ANY LEAK. A DEVICE HISTORY REVIEW WAS PERFORMED FOR SUSPECTED LOT 2112057, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. MOLDING PARAMETERS WERE REVIEWED FOR THE REPORTED LOT AND FOUND MACHINES WERE OPERATING WITHIN REQUIRED LIMITS. TEN RETAINED SAMPLES OF LOT 2112057 WERE USED FOR ADDITIONAL EVALUATION. ALL PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR OTHER DEFECTS WERE OBSERVED. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES, INCLUDING TIP AND THREAD VERIFICATIONS. RESULTS WERE REVIEWED FOR THE REPORTED LOT AND NO ISSUES RELATED TO THIS INCIDENT WERE IDENTIFIED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PLASTIPAK¿ 1 ML SYRINGES LEAKAGE OCCURRED. THIS OCCURRED TWICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THAT DAY, THE DR. GAVE A CAT AN INJECTION OF VITAMIN B12 AND A GOOD PART OF THE PRODUCT RAN BETWEEN THE SYRINGE AND THE NEEDLE AND SPREAD ON THE CAT AND ON THE TABLE. IN THE AFTERNOON, SHE TRIED TO SEDATE A CAT IM, AND AGAIN THE SAME PROBLEM, THE CAT DIDN'T GET ITS DOSE BUT WE DIDN'T KNOW HOW MUCH THE ANIMAL HAD RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PLASTIPAK¿ 1 ML SYRINGES LEAKAGE OCCURRED. THIS OCCURRED TWICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THAT DAY, THE DR. GAVE A CAT AN INJECTION OF VITAMIN B12 AND A GOOD PART OF THE PRODUCT RAN BETWEEN THE SYRINGE AND THE NEEDLE AND SPREAD ON THE CAT AND ON THE TABLE. IN THE AFTERNOON, SHE TRIED TO SEDATE A CAT IM, AND AGAIN THE SAME PROBLEM, THE CAT DIDN'T GET ITS DOSE BUT WE DIDN'T KNOW HOW MUCH THE ANIMAL HAD RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158547 BD PLASTIPAK¿ 1 ML SYRINGES PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2112057

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown