BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML LUER-LOK SYRINGE

    MDR report key: 8898636 · Received August 15, 2019

    Report

    Report Number
    3003152976-2019-00551
    Event Type
    Malfunction
    Date Received
    August 15, 2019
    Date of Event
    July 25, 2019
    Report Date
    November 6, 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

    H.6. INVESTIGATION SUMMARY: NO PHOTOS OR SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1811239, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. AREAS WHERE PRODUCT MOVED WITHIN THE MACHINES ARE PROTECTED TO AVOID CREATING ANY DAMAGE. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE AT THIS TIME. A PROJECT WAS INITIATED TO LOOK FURTHER INTO THIS ISSUE AND REDUCE ANY REOCCURRENCE. MANUFACTURING PERSONNEL HAVE BEEN MADE AWARE TO INCREASE AWARENESS OF THIS MATTER. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE SAMPLE WAS RETURNED TO OUR QUALITY ENGINEER FOR INVESTIGATION. UPON VISUALLY INSPECTING THE PRODUCT, THE SYRINGE BARREL IS OBSERVED TO BE DAMAGED, DENTED NEAR THE 30ML MAKING. WHEN MOVING THE STOPPER ACROSS THIS POINT, THE STOPPER BECOMES DISTORTED AGAINST THE BARREL WALL, RESULTING IN THE LEAKAGE THAT WAS REPORTED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1811239, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. AREAS WHERE PRODUCT MOVED WITHIN THE MACHINES ARE PROTECTED TO AVOID CREATING ANY DAMAGE. ALTHOUGH WE COULD NOT IDENTIFY A DIRECT ISSUE, IT WAS DETERMINED THIS INCIDENT OCCURRED DUE THE PRODUCT JAMMING WITHIN THE MANUFACTURING EQUIPMENT. A PROJECT WAS INITIATED TO LOOK FURTHER INTO THIS ISSUE AND REDUCE ANY REOCCURRENCE. MANUFACTURING PERSONNEL HAVE BEEN MADE AWARE OF THE MALFUNCTION TO INCREASE AWARENESS OF THIS MATTER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DEFORMED SYRINGE WAS FOUND DURING USE WITH A BD PLASTIPAK¿ 50ML LUER-LOK SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DEFORMED SYRINGE CAUSING SOLVENT LEAKAGE WHEN THE PLUNGER IS PUSHED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DEFORMED SYRINGE WAS FOUND DURING USE WITH A BD PLASTIPAK¿ 50ML LUER-LOK SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DEFORMED SYRINGE CAUSING SOLVENT LEAKAGE WHEN THE PLUNGER IS PUSHED."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 DEFORMED SYRINGE WAS FOUND DURING USE WITH A BD PLASTIPAK¿ 50ML LUER-LOK SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DEFORMED SYRINGE CAUSING SOLVENT LEAKAGE WHEN THE PLUNGER IS PUSHED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690189 BD PLASTIPAK 50ML LUER-LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1811239

    Patients

    Seq Age Sex Outcome Treatment
    1 Other