BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 8510220 · Received April 12, 2019

    Report

    Report Number
    3003152976-2019-00267
    Event Type
    Malfunction
    Date Received
    April 12, 2019
    Date of Event
    March 28, 2019
    Report Date
    April 16, 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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: 1 SEALED SAMPLE HAS BEEN RECEIVED OF 50LL LOT 1901236 AND 2 PICTURES FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE SAMPLE AND PICTURES RECEIVED, IT CAN BE OBSERVED THE STOPPER IS WRONG ASSEMBLED TO THE PLUNGER, IT DISTORTED AGAINST BARREL WALLS. DHR OF LOT 1901236 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 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): 1.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. 2.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 ESTABLISHED 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DEFORMED STOPPER OCCURRED WITH A BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "BEFORE OPENING THE PACKAGING, THE NURSE NOTICED THAT THE PLUNGER SEAL WAS DEFORMED."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEFORMED STOPPER OCCURRED WITH A BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "BEFORE OPENING THE PACKAGING, THE NURSE NOTICED THAT THE PLUNGER SEAL WAS DEFORMED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305034 BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1901236 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other