BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 13838980 · Received March 21, 2022

    Report

    Report Number
    3003152976-2022-00109
    Event Type
    Malfunction
    Date Received
    March 21, 2022
    Date of Event
    February 8, 2022
    Report Date
    April 28, 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 IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 21-MAR-2022. H6: INVESTIGATION SUMMARY: TWO SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A TRANSPARENT RESIDUE WAS OBSERVED ON THE STOPPER OF THE SYRINGES, A HIGHER QUANTITY NOTED IN ONE OF THE SAMPLES. THROUGH OUR EVALUATION, THE RESIDUE WAS IDENTIFIED TO BE SILICONE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2110136, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. LUBRICANT IS EMPLOYED DURING THE SYRINGE ASSEMBLY PROCESS TO LUBRICATE THE CYLINDERS IN THE SILICONE STATION. THE SILICONE EMPLOYED IN THIS PRODUCT IS A MEDICAL GRADE SILICONE AUTHORIZED FOR PRODUCT USE. SILICONE CONTENT TESTS ARE PERFORMED DURING THE MANUFACTURING PROCESS OF EACH LOT NUMBER. RESULTS WERE REVIEWED FOR LOT 2110136 AND FOUND TO BE WITHIN SPECIFICATION. THE RETURNED SAMPLES UNDERWENT THE SAME TESTING, VERIFYING ONE SAMPLE WAS ABOVE THE SPECIFIED LIMIT, THE SECOND SYRINGE WAS WITHIN REQUIRED LIMITS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT GREASE-LIKE FOREIGN MATTER WAS FOUND ON 2 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGES' PLUNGER TIPS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "PROBLEM OBSERVED: INSIDE THE SYRINGE, ON THE TIP OF THE PLUNGER, DEPOSIT OF A LAYER OF GREASE IMMEDIATE ACTION: DEVICE CHANGE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT GREASE-LIKE FOREIGN MATTER WAS FOUND ON 2 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGES' PLUNGER TIPS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "PROBLEM OBSERVED: INSIDE THE SYRINGE, ON THE TIP OF THE PLUNGER, DEPOSIT OF A LAYER OF GREASE IMMEDIATE ACTION: DEVICE CHANGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651155 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2110136

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown