BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 10103160 · Received May 29, 2020

    Report

    Report Number
    3003152976-2020-00229
    Event Type
    Malfunction
    Date Received
    May 29, 2020
    Date of Event
    April 28, 2020
    Report Date
    May 14, 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
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON INSPECTING THE PHOTO, LIQUID WAS OBSERVED BELOW THE STOPPER, VERIFYING THE REPORTED INCIDENT. THERE IS NO VISIBLE DAMAGE ON THE SYRINGE OR STOPPER THAT WE COULD IDENTIFY THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2002241, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF LOT 2002241 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. 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. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. INVESTIGATION CONCLUSION: IT HAS BEEN RECEIVED TWO PICTURES FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE PICTURES, IT CAN BE CONFIRMED THAT THERE IS LIQUID BELOW THE STOPPER CONFIRMING THE LEAK BUT NO DAMAGE CAN BE SEEN ON THE SYRINGE OR STOPPER TO DETERMINE THE CAUSE OF THE LEAK. DHR OF LOT 2002241 HAS BEEN REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING THE ALLEGED DEFECT. THE FAILURE MODES AND EFFECTS ANALYSIS FOR PROCESSES AR-2D05 PLASTIPAK SYRINGES ASSEMBLY WAS REVIEWED AND FAILURE ADEQUATELY ASSESSED. TEN RETAINED SAMPLES OF 50 LL LOT 2002241 ARE EVALUATED. 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 PC-039 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. TIGHTNESS TEST IS PERFORMED TO EVERY SYRINGE IN ASSEMBLY STATION DURING MANUFACTURING PROCESS. IN CASE ANY FAILS IT IS REJECTED TO SCRAP AUTOMATICALLY. ACCORDING TO INSPECTION PLAN PROCEDURE JG-500, 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 (JG-301, JG-302, JG-303 AND JG-304): 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. PACKAGING: 1 BOX PER PALLET. FUNCTIONAL INSPECTION: PRINTING: ONCE IN THE FIRST PALLET, ONCE IN THE LAST PALLET OF THE LOT PLUS ONCE PER DAY. ASSEMBLY: ONCE IN THE FIRST PALLET, ONCE IN THE LAST PALLET OF THE LOT PLUS ONCE PER DAY. 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: SINCE ROOT CAUSE CANNOT BE DETERMINED, NO CORRECTIVE ACTION IS TAKEN AT THIS TIME. 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 ANTICANCER MEDICATION LEAKED PAST THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE STOPPER DURING USE AND ONTO THE NURSE'S GLOVES. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "USE A 50 ML SYRINGE TO REMOVE AN ANTICANCER FROM A VIAL. DURING THE SAMPLING, OBSERVATION OF A FEW DROPS OF ANTICANCER THAT PASS BETWEEN THE BLACK SEAL OF THE PISTON AND THE WALL OF THE SYRINGE. WHEN THE ANTICANCER WAS INJECTED INTO THE POUCH, THE SAME THING HAPPENED: A LEAK IN THE PISTON SEAL AND THE ANTICANCER POURED INTO THE BODY OF THE SYRINGE, DIRECT CONTACT WITH THE PICKER¿S GLOVES." "NO RISK FOR THE PATIENT BUT THE NURSE'S GLOVES HAVE BEEN CONTAMINATED AND THERE WAS A RISK DURING THE MANIPULATION TO BE IN CONTACT WITH THE ANTICANCER PRODUCT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563614 BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2002241

    Patients

    Seq Age Sex Outcome Treatment
    1 Other