BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML LS SP120

    MDR report key: 12485103 · Received September 16, 2021

    Report

    Report Number
    3003152976-2021-00604
    Event Type
    Malfunction
    Date Received
    September 16, 2021
    Date of Event
    August 20, 2021
    Report Date
    October 5, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-09-27. H6: INVESTIGATION SUMMARY: SAMPLES AND PHOTOS RECEIVED FOR INVESTIGATION, UPON VISUAL INSPECTION IT CAN BE OBSERVED TWO OF THE SYRINGES HAVE BOWED PLUNGER. THIS DEFECT CAN BE CAUSED BY A HIT DURING MANUFACTURING PROCESS WHEN THE PARTS ARE ALREADY ASSEMBLED. PARTS CAN GET DEFORMED BY A HIT IF THEY DO NOT COOL CORRECTLY. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2102021, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. 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. THE POSSIBLE ROOT CAUSE OF THIS DEFECT CAN BE RELATED WITH A HIT TO THE PLUNGER WHEN THE PART WAS NOT COMPLETELY COOLED. 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 H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 BD ALARIS¿ SMARTSITE¿ EXTENSION SETS' PLUNGER RODS WERE CURVED/DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: "PACKAGING BD PLASTIPAK 1ML SYRINGE CONTAINS SYRINGES WITH A ¿CURVED¿ PLUNGER."

    Additional Manufacturer Narrative · 1

    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 5 BD ALARIS¿ SMARTSITE¿ EXTENSION SETS' PLUNGER RODS WERE CURVED/DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "PACKAGING BD PLASTIPAK 1ML SYRINGE CONTAINS SYRINGES WITH A ¿CURVED¿ PLUNGER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1379595 SYRINGE 1ML LS SP120 PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2102021

    Patients

    Seq Age Sex Outcome Treatment
    1