BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 8440350 · Received March 21, 2019

    Report

    Report Number
    3003152976-2019-00215
    Event Type
    Malfunction
    Date Received
    March 21, 2019
    Date of Event
    February 14, 2019
    Report Date
    March 7, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903008650
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). INVESTIGATION SUMMARY: ONE PHYSICAL SAMPLE AND MULTIPLE PHOTOS WERE PROVIDED TO OUR QUALITY ENGINEER FOR INVESTIGATION. THROUGH VISUAL INSPECTION IT WAS OBSERVED THAT THE STOPPER WAS INCORRECTLY ASSEMBLED TO THE PLUNGER, PARTIALLY DETACHED. A DEVICE HISTORY WAS PERFORMED AND FOUND NO NO-CONFORMANCES RELATED TO THE REPORTED ISSUE DURING PRODUCTION OF BATCH 1812255 . THIS ISSUE WAS DETERMINED TO HAVE OCCURRED AS A RESULT OF IMPROPER ALIGNMENT OF THE PLUNGER/STOPPER TO THE BARREL DURING ASSEMBLY. A CAMERA SYSTEM HAS SINCE BEEN INSTALLED TO HELP DETECT THIS ISSUE. THE AREA MANAGER HAS BEEN MADE AWARE OF YOUR EXPERIENCE TO INCREASE AWARENESS OF THIS MATTER. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED FOR FUTURE OCCURRENCE. INVESTIGATION CONCLUSION: DEFECT: STOPPER WRONG ASSEMBLED. IT HAS BEEN RECEIVED 1 UNUSED SAMPLE OF 50LL WITHOUT BLISTER FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE SAMPLE RECEIVED, IT CAN BE OBSERVED THE STOPPER IS WRONG ASSEMBLED TO THE PLUNGER, IT IS PARTIALLY DETACHED FROM PLUNGER. DHR OF LOT 1812255 HAS BEEN REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING THE ALLEGED DEFECT. THIS DEFECT HAS BEEN CAUSED BECAUSE THE PLUNGER-STOPPER WAS NOT CORRECTLY ALIGNED TO THE BARREL AT THE MOMENT OF ASSEMBLY. THERE IS A CAMERA IN THE ASSEMBLY STATION TO DETECT STOPPER WRONG ASSEMBLED OR MISSING STOPPER. SINCE NO INCIDENCE HAS BEEN FOUND DURING MANUFACTURING PROCESS THE ROOT CAUSE OF THIS MISALIGNMENT OR LACK IN DETECTION CANNOT BE DETERMINED. 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. ALTHOUGH NO ISSUES WERE IDENTIFIED AND MANUFACTURING RECORD STABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY, WE CAN CONFIRM THAT THE ROOT CAUSE OF THE NON-CONFORMANCE IS RELATED WITH A MISALIGNMENT OF PLUNGER-STOPPER-BARREL IN THE ASSEMBLY STATION. BASED ON ALL THE PREVENTIVE MEASURES AND OUR STRINGENT IN ¿PROCESS INSPECTION PLAN, WE ARE CERTAIN THAT THIS SHOULD BE AN ISOLATED ISSUE AND ANY RECURRENCE IS REALLY UNLIKELY BASED ON NO QUALITY NOTIFICATION WAS OPENED DURING MANUFACTURING PROCESS OF THIS LOT. IN ORDER TO REINFORCE OUR CUSTOMER SATISFACTION, WE WOULD LIKE TO INFORM YOU THAT OUR MANUFACTURING FACILITY WAS ALERTED OF YOUR EXPERIENCE, RAISING THE AWARENESS ON THE PRODUCTION FLOOR IN ORDER TO PAY MORE ATTENTION TO THIS MATTER. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: MISALIGNMENT OF PLUNGER-STOPPER-BARREL IN THE ASSEMBLY STATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE HAD A DEFECTIVE STOPPER. THE FOLLOWING WAS REPORTED, "THE 50 ML BD SYRINGE (LOT 1812255 EXPIRATION 2023-11) WAS REMOVED FROM THE PACKAGE IN THE DEPARTMENT OF CYTOSTATIC PREPARATION. BEFORE EACH MEDICATION IS DRAWN UP, A CHECK OF THE FUNCTION OF THE SYRINGE IS MADE AND THE AIR IS PUSH OUT OF THE SYRINGE. IN THIS PROCESS, THE STOPPER FALL OUT. THE SYRINGE WAS NOT USED. THE SYRINGE CAN BE COLLECTED. A WRITTEN STATEMENT FROM THE MANUFACTURER IS DESIRED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234772 BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1812255 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other