BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE ¿ IV CATHETER

    MDR report key: 7850687 · Received September 6, 2018

    Report

    Report Number
    3003152976-2018-00409
    Event Type
    Malfunction
    Date Received
    September 6, 2018
    Date of Event
    June 15, 2018
    Report Date
    October 11, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FOZ
    UDI-DI
    00382903885121
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: QUANTITY OF CUSTOMER SAMPLES: 5 SAMPLES OF 30LL LOT 1802267. DATE CUSTOMER SAMPLES RECEIVED: 25/SEP/2018. IT HAS BEEN RECEIVED 5 SAMPLES OF 30LL LOT 1802267 FOR INVESTIGATION. UPON VISUAL INSPECTION OF THESE FIVE SAMPLES, IT CAN BE OBSERVED THE FIVE BLISTERS ARE OPEN BECAUSE THEY WERE INCORRECTLY CUT. DHR OF LOT 1802267 HAS BEEN REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING THE ALLEGED DEFECT. THE ROOT CAUSE OF THIS DEFECT IS RELATED WITH A DISPLACEMENT OF THE PAPER DURING PACKING PROCESS CAUSING THE BLISTERS WERE NOT CORRECTLY SEALED AND RESULTING OPENED. 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: 10 SAMPLES PER TWO HOURS, AFTER ANY INTERVENTION IN THE EQUIPMENT AND ONCE AT THE BEGINNING OF THE SHIFT. ASSEMBLY: 10 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 TWO HOURS, 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 PALLET#1, ONCE IN PALLET#7, ONCE IN PALLET#14 AND ONCE IN PALLET#22. ASSEMBLY: ONCE IN PALLET#1, ONCE IN PALLET#7, ONCE IN PALLET#14 AND ONCE IN PALLET#22. PRIMARY PACKAGING: ONCE IN PALLET#1, ONCE IN PALLET#7, ONCE IN PALLET#14 AND ONCE IN PALLET#22. 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 DISPLACEMENT OF THE PAPER DURING PACKING PROCESS CAUSING THE BLISTERS WERE NOT CORRECTLY SEALED AND RESULTING OPENED. INVESTIGATION CONCLUSION: THE ROOT CAUSE OF THIS DEFECT IS RELATED WITH A DISPLACEMENT OF THE PAPER DURING PACKING PROCESS CAUSING THE BLISTERS WERE NOT CORRECTLY SEALED AND RESULTING OPENED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE ¿ IV CATHETER HAD DEFECTIVE PACKAGING THAT LED TO A BREACH IN THE STERILE BARRIER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSYTE ¿ IV CATHETER HAD DEFECTIVE PACKAGING THAT LED TO A BREACH IN THE STERILE BARRIER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691949 BD INSYTE ¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON, S.A. 1802267 00382903885121

    Patients

    Seq Age Sex Outcome Treatment
    1 Other