BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ STERILE PLASTIC SYRINGE

    MDR report key: 13428879 · Received February 2, 2022

    Report

    Report Number
    9614033-2022-00008
    Event Type
    Malfunction
    Date Received
    February 2, 2022
    Date of Event
    January 18, 2022
    Report Date
    June 16, 2022
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. 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

    H.6 INVESTIGATION SUMMARY: TWO 10 ML SYRINGES AND PHOTOS RECEIVED FOR INVESTIGATION. UPON VISUAL INSPECTION, NO MOLDING DEFECTS OBSERVED FOR BATCH 1131406, HOWEVER DISCOLORATION ON THE PLUNGER IS OBSERVED. THIS IS A COSMETIC DEFECT THAT DO NOT AFFECT FUNCTIONALITY OF THE SYRINGE. NO MOLDING DEFECTS, LOOSE PARTICLES IN THE FLUID PATH, OR EMBEDDED PARTICLES OBSERVED ON SAMPLE FOR BATCH 1131415, HOWEVER EXCESS SILICONE COULD BE OBSERVED. TESTING WAS PERFORMED ON THE SAMPLE, RESULTS VERIFIED AMOUNT OF SILICONE WAS NOT WITHIN THE REQUIRED LIMITS. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOTS 1131406, 1131415 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. POSSIBLE ROOT CAUSE FOR DISCOLORATION ON THE SYRINGE IS ASSOCIATION WITH THE CLEANING CONDITION IN THE MOLDING PROCESS. ACTION INCLUDE MONTHLY MAINTENANCE CLEANING PLAN. POSSIBLE ROOT CAUSE FOR VISIBLE SILICONE IS ASSOCIATED WITH DAMAGE TO THE SILICONE NOZZLE. ACTIONS INCLUDE, UPDATE MACHINERY PARTS EVERY SIX MONTHS AND MAINTENANCE ROUTINE TO THE SILICONE INJECTION SYSTEM.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PLASTIPAK¿ STERILE PLASTIC SYRINGE FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MORE PRODUCTS (IN THE LAST 30 DAYS) EXHIBITED QUALITY DEVIATIONS AND ONE OF THEM AGAIN SHOWED A STRANGE LIQUID ELEMENT INSIDE. ADD INFORMATION RECEIVED ON 21 JAN 2022: WHAT ARE THE OTHER IDENTIFIED DEVIATIONS AND THEIR BATCHES? LOT: 1131415. DEVIATION: A TRANSPARENT VISCOUS LIQUID WITH AN OILY APPEARANCE IS FOUND INSIDE THE CYLINDER. WHAT IS THE LOT AND CATALOG OF THE AFFECTED NEW PRODUCTS? (RELATE THE DEFECT TO THE BATCH/CATALOG) LOT: 1131415, REF 302558. THE AMOUNT INVOLVED FOR EACH OF THE DEFECTS? LOT: 1131415, REF 302558. QUANTITY: 1 UNIT REPORTED AND WITHHELD, IN PRACTICE UNKNOWN. WAS THE REPORTED INCIDENT NOTED BEFORE, DURING OR AFTER USE? LOT: 1131415, REF 302558. DURING USE. SO FAR, NO ADVERSE EVENT HAS BEEN ASSOCIATED WITH THE USE OF SYRINGES WITH QUALITY DEVIATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PLASTIPAK¿ STERILE PLASTIC SYRINGE FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MORE PRODUCTS (IN THE LAST 30 DAYS) EXHIBITED QUALITY DEVIATIONS AND ONE OF THEM AGAIN SHOWED A STRANGE LIQUID ELEMENT INSIDE. ADD INFORMATION RECEIVED ON 21 JAN 2022: WHAT ARE THE OTHER IDENTIFIED DEVIATIONS AND THEIR BATCHES? LOT: 1131415. DEVIATION: A TRANSPARENT VISCOUS LIQUID WITH AN OILY APPEARANCE IS FOUND INSIDE THE CYLINDER. WHAT IS THE LOT AND CATALOG OF THE AFFECTED NEW PRODUCTS? (RELATE THE DEFECT TO THE BATCH/CATALOG) LOT: 1131415, REF 302558. THE AMOUNT INVOLVED FOR EACH OF THE DEFECTS? LOT: 1131415, REF 302558. QUANTITY: 1 UNIT REPORTED AND WITHHELD, IN PRACTICE UNKNOWN. WAS THE REPORTED INCIDENT NOTED BEFORE, DURING OR AFTER USE? LOT: 1131415, REF 302558. DURING USE. SO FAR, NO ADVERSE EVENT HAS BEEN ASSOCIATED WITH THE USE OF SYRINGES WITH QUALITY DEVIATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233972 BD PLASTIPAK¿ STERILE PLASTIC SYRINGE PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 1131415

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown