BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 10099379 · Received May 28, 2020

    Report

    Report Number
    3003152976-2020-00227
    Event Type
    Malfunction
    Date Received
    May 28, 2020
    Date of Event
    May 5, 2020
    Report Date
    May 11, 2020
    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

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2003241, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF LOT 2003241 WERE USED TO CONDUCT A LEAKAGE TEST. THE PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS OR DAMAGE WAS NOTED, THE STOPPER WAS PROPERLY ASSEMBLED ONTO THE PLUNGER, AND NO LEAK WAS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME. INVESTIGATION CONCLUSION: DHR OF LOT 2003241 HAS BEEN REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING THE ALLEGED DEFECT. TEN RETAINED SAMPLES OF 50 LL LOT 2003241 WAS EVALUATE. UPON VISUAL INSPECTION OF THESE 10 SAMPLES, NO DAMAGE OR MOLDING DEFECT CAN BE OBSERVED IN ANY OF THEM THAT COULD CAUSE LEAKAGE. THE STOPPER IS CORRECTLY ASSEMBLED TO THE PLUNGER IN THE TEN SAMPLES. LEAK TEST IS ALSO CARRIED OUT WITH THE 10 RETAINED SAMPLES ACCORDING TO PROCEDURE (B)(4) AND ISO 7886-1 ANNEX D. ALL OF THEM MEET ISO 7886-1 ANNEX D. THEY ARE DISASSEMBLED NOT OBSERVING ANY DAMAGE IN PLUNGER ROD THAT COULD HAVE CAUSED LEAKAGE. ACCORDING TO INSPECTION PLAN PROCEDURE (B)(4), 200 UNITS ARE INSPECTED EVERY 2 PALLETS BY QUALITY CONTROL TEAM. IN ADDITION, FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE AND LOT SIZE ARE SAMPLED BY OPERATOR AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES (B)(4): VISUAL INSPECTION: MOLDING: 2 INJECTIONS PER SHIFT. PRINTING: 32 SAMPLES PER TWO HOURS, AFTER ANY INTERVENTION IN THE EQUIPMENT AND ONCE AT THE BEGINNING OF THE SHIFT. ASSEMBLY: 32 SAMPLES PER TWO HOURS, AFTER ANY INTERVENTION IN THE EQUIPMENT AND ONCE AT THE BEGINNING OF THE SHIFT. PRIMARY PACKAGING: 1 ADVANCE-STEP (WITHOUT PRODUCT) PER HOUR, AFTER ANY INTERVENTION IN THE EQUIPMENT, AND ONCE AT THE BEGINNING OF THE SHIFT. SECONDARY PACKAGING: 1 SHELF-PACKAGE PER PALLET. FUNCTIONAL INSPECTION: PRINTING: ONCE IN THE FIRST PALLET AND ONCE IN LAST PALLET OF THE LOT. ASSEMBLY: ONCE IN THE FIRST PALLET AND ONCE IN LAST PALLET OF THE LOT PRIMARY PACKAGING: ONCE IN THE FIRST PALLET AND ONCE IN LAST PALLET OF THE LOT. SINCE NO MANUFACTURING DEFECT CAN BE OBSERVED IN RETAINED SAMPLES EVALUATED AND SINCE THEY MEET ISO 7886-1 ANNEX D FOR LEAK TEST, THE ROOT CAUSE OF THE ALLEGED DEFECT CANNOT BE DETERMINED. ROOT CAUSE DESCRIPTION: CANNOT BE DETERMINED. RATIONALE: BASED ON QDA LIMITS FOR THIS PRODUCT AND DEFECT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LIQUID LEAKED PAST THE PLUNGER INTO THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE BODY WHILE PERFORMING A "5-FU" PREPARATION DURING USE. THIS OCCURRED ON 2 SEPARATE OCCASIONS, BUT THE DATES AND/OR PATIENT INFORMATION ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "WHEN PERFORMING A 5-FU PREPARATION, THE PREP OBSERVED THE PRESENCE OF LIQUID IN THE SYRINGE BODY, BEYOND THE PISTON SEAL.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558637 BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2003241

    Patients

    Seq Age Sex Outcome Treatment
    1 Other