BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 10269473 · Received July 14, 2020

    Report

    Report Number
    3003152976-2020-00305
    Event Type
    Malfunction
    Date Received
    July 14, 2020
    Date of Event
    June 22, 2020
    Report Date
    August 14, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL YES. D.10 RETURNED TO MANUFACTURER ON: 2020-08-04. H.6. INVESTIGATION SUMMARY THREE UNUSED SAMPLES OF LOT 2002224 AND THREE UNUSED SAMPLES OF LOT 2001235 WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR MOLDING DEFECT WAS OBSERVED ON THE PLUNGER ROD OR ANY OTHER COMPONENTS THAT COULD CONTRIBUTE TO THE REPORTED LEAK AND THE STOPPER WAS PROPERLY ASSEMBLED ONTO THE PLUNGER. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOTS 2002224 AND 2001235, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. LEAKAGE TESTING WAS PERFORMED ON THE SAMPLES AND ALL PRODUCT MET REQUIRED SPECIFICATION, NO LEAKAGES WERE OBSERVED. 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. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PLUNGER WASN'T SEALED AND DRAWN UP SOLUTION "SPRAYED" BEHIND THE PISTON DURING USE. LOT#'S 2002224 AND 2001235 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "WHEN THE SYRINGES ARE EMPTIED, THE PLUNGERS ARE NO LONGER SEALED, SO THAT DRAWN UP SOLUTION SPRAYS OUT BEHIND THE PISTON."

    Additional Manufacturer Narrative · 1

    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 #: 2002224, DEVICE MANUFACTURE DATE: 2020-02-10, MEDICAL DEVICE LOT #: 2001235. DEVICE MANUFACTURE DATE: 2020-01-15. INITIAL REPORTER PHONE#: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE PLUNGER WASN'T SEALED AND DRAWN UP SOLUTION "SPRAYED" BEHIND THE PISTON DURING USE. LOT#'S 2002224 AND 2001235 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "WHEN THE SYRINGES ARE EMPTIED, THE PLUNGERS ARE NO LONGER SEALED, SO THAT DRAWN UP SOLUTION SPRAYS OUT BEHIND THE PISTON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737960 BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other