BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 10502739 · Received September 8, 2020

    Report

    Report Number
    3003152976-2020-00397
    Event Type
    Malfunction
    Date Received
    September 8, 2020
    Date of Event
    August 13, 2020
    Report Date
    September 28, 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

    H.6. INVESTIGATION: TWO SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON RECEIPT, THE PRODUCT WAS INDICATED TO BE CHEMO CONTAMINATED AND UNFORTUNATELY, COULD NOT BE FULLY EVALUATED. DURING A VISUAL INSPECTION, WE WERE ABLE TO IDENTIFY A LEAK BETWEEN THE STOPPER RIBS. THERE WAS NO VISUAL DEFECTS OR DAMAGE THAT COULD BE OBSERVED THAT COULD HAVE CONTRIBUTED TO THE LEAK. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2003223, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF LOT 2003223 WERE USED TO PERFORM LEAKAGE TESTING. THE PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS OR DAMAGE WAS NOTED, THE STOPPERS WERE PROPERLY ASSEMBLED ONTO THE PLUNGER, AND NO LEAK WAS IDENTIFIED. 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 DETERMINE A ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE LEAKED PAST THE STOPPER. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "LEAKAGE OF THE SYRINGE PLUNGER OF BD PLASTIPAK LUER-LOK SYRINGES WHEN USING CYTOSTATIC SOLUTION. WHETHER THE LEAKAGE IS CAUSED BY THE CYTOSTATIC SOLUTION OR IS DUE TO SOME OTHER DEFECT THST HAS NOT BEEN DETERMINED YET." "- 2 PIECES BD PLASTIPAK LUER-LOK SYRINGE 50 ML - 1 PIECE BD PLASTIPAK LUER-LOK SYRINGE 10 LEAKAGE PAST THE RUBBER STOPPER, PLUNGER DOES NOT FIT TIGHTLY TO THE INNER WALL OF THE BARREL. 2 SYRINGES WRAPPED IN PLASTIC FOIL"

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE#: (B)(6). INITIAL REPORTER FAX#: (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 LEAKED PAST THE STOPPER. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "LEAKAGE OF THE SYRINGE PLUNGER OF BD PLASTIPAK LUER-LOK SYRINGES WHEN USING CYTOSTATIC SOLUTION. WHETHER THE LEAKAGE IS CAUSED BY THE CYTOSTATIC SOLUTION OR IS DUE TO SOME OTHER DEFECT THAT HAS NOT BEEN DETERMINED YET." "2 PIECES BD PLASTIPAK LUER-LOK SYRINGE 50 ML. 1 PIECE BD PLASTIPAK LUER-LOK SYRINGE 10. LEAKAGE PAST THE RUBBER STOPPER, PLUNGER DOES NOT FIT TIGHTLY TO THE INNER WALL OF THE BARREL. 2 SYRINGES WRAPPED IN PLASTIC FOIL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970110 BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2003223

    Patients

    Seq Age Sex Outcome Treatment
    1 Other