BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 14406983 · Received May 16, 2022

    Report

    Report Number
    3003152976-2022-00213
    Event Type
    Malfunction
    Date Received
    May 16, 2022
    Date of Event
    April 20, 2022
    Report Date
    June 7, 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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2111031, MEDICAL DEVICE EXPIRATION DATE: 31-OCT-2026, DEVICE MANUFACTURE DATE: 15-NOV-2021; MEDICAL DEVICE LOT #: 2202018, MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2027, DEVICE MANUFACTURE DATE: 07-FEB-2022; MEDICAL DEVICE LOT #: 2110047, MEDICAL DEVICE EXPIRATION DATE: 30-SEP-2026, DEVICE MANUFACTURE DATE: 08-OCT-2021. 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: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 10-MAY-2022. H.6. INVESTIGATION: SEVERAL SAMPLES AND ONE PHOTO WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION OF BOTH THE PHOTO AND SAMPLES, SILICONE CAN BE OBSERVED, HOWEVER, IT CANNOT BE CONFIRMED IT IS IN EXCESS. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOTS 2111031, 2202018 AND 21110047, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TESTING WAS PERFORMED ON THE RETURNED SAMPLES, ALL PRODUCT MET REQUIRED SPECIFICATION AND RESULTS VERIFIED THE AMOUNT OF SILICONE WAS WITHIN REQUIRED LIMITS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE EACH FROM LOTS 2111031, 2202018, AND 2110047 HAD VISIBLE SILICONE ON THEIR PLUNGERS. ADDITIONALLY, ONE OF THE SYRINGES HAD DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "THE INTENSIVE CARE UNIT IS A HEAVY USER OF 50 ML LOCKING SYRINGES REF 300865. IDES NOTE THAT LUBRICANT REMAINS ARE PRESENT IN THE SYRINGES WHEN THE PLUNGER IS MOVED. THIS IS THE CASE FOR SEVERAL BATCHES." "TO COMPLETE OUR STATEMENT, IN FACT ON ONE UNIT, IT WAS DIFFICULT TO DISENGAGE THE PLUNGER FROM THE END OF THE SYRINGE TIP." "THE DEPOSIT ON THE INCRIMINATED SYRINGES WAS MUCH MORE IMPORTANT TO THE POINT OF HAVING HAD SILICONE ON THE TIP OF THE LUER LOCK AND THERE WAS A VERY STRONG RESISTANCE WHEN THEY PULLED ON THE PISTON."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE EACH FROM LOTS 2111031, 2202018, AND 2110047 HAD VISIBLE SILICONE ON THEIR PLUNGERS. ADDITIONALLY, ONE OF THE SYRINGES HAD DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "THE INTENSIVE CARE UNIT IS A HEAVY USER OF 50 ML LOCKING SYRINGES REF 300865. IDES NOTE THAT LUBRICANT REMAINS ARE PRESENT IN THE SYRINGES WHEN THE PLUNGER IS MOVED. THIS IS THE CASE FOR SEVERAL BATCHES". "TO COMPLETE OUR STATEMENT, IN FACT ON ONE UNIT, IT WAS DIFFICULT TO DISENGAGE THE PLUNGER FROM THE END OF THE SYRINGE TIP.". "THE DEPOSIT ON THE INCRIMINATED SYRINGES WAS MUCH MORE IMPORTANT TO THE POINT OF HAVING HAD SILICONE ON THE TIP OF THE LUER LOCK AND THERE WAS A VERY STRONG RESISTANCE WHEN THEY PULLED ON THE PISTON.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1746116 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE SECTION H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown