BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGE

    MDR report key: 8355830 · Received February 20, 2019

    Report

    Report Number
    3003152976-2019-00171
    Event Type
    Malfunction
    Date Received
    February 20, 2019
    Date of Event
    April 16, 2018
    Report Date
    March 7, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT HAS BEEN RECEIVED 1 USED SAMPLE WITH OPEN BLISTER OF 50LL LOT 1801251 FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE USED SAMPLE RECEIVED NO LEAKAGE CAN BE APPRECIATED THROUGH THE STOPPER, NEITHER ANY DAMAGE ON SYRINGE THAT COULD HAVE CAUSED LEAKAGE. DHR OF LOT 1801251 HAS BEEN REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING THE ALLEGED DEFECT. USED SAMPLE RECEIVED IS DISASSEMBLED NOT OBSERVING ANY DAMAGE IN PLUNGER ROD OR ANY OF THEIR COMPONENTS THAT COULD HAVE CAUSED LEAKAGE. LEAK TEST CANNOT BE PERFORMED WITH USED SAMPLE RECEIVED, SINCE SYRINGES ARE SINGLE USE SO, TEN RETAINED SAMPLES OF 50LL LOT 1801251 ARE EVALUATED. UPON VISUAL INSPECTION OF THESE TEN SAMPLES, NO DAMAGE CAN BE OBSERVED IN THEM THAT COULD CAUSE LEAKAGE AND THE STOPPER IS CORRECTLY ASSEMBLED TO THE PLUNGER IN ALL OF THEM. LEAK TEST IS CARRIED OUT WITH THESE 10 RETAINED SAMPLES ACCORDING TO PROCEDURE PC-039 AND ISO 7886-1 ANNEX D. THE 10 SAMPLES MEET ISO 7886-1 ANNEX D. THEY ARE DISASSEMBLED NOT OBSERVING ANY DAMAGE IN PLUNGER ROD OR ANY OF THEIR COMPONENTS THAT COULD HAVE CAUSED LEAKAGE. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE AND LOT SIZE ARE SAMPLED 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 OF THE LOT AND ONCE IN LAST PALLET OF THE LOT. -ASSEMBLY: ONCE IN THE FIRST PALLET OF THE LOT AND ONCE IN LAST PALLET OF THE LOT. -PRIMARY PACKAGING: ONCE IN THE FIRST PALLET OF THE LOT AND ONCE IN LAST PALLET OF THE LOT. THIS ISSUE IS NOT RELATED TO A MANUFACTURING DEFECT. SINCE NO INCIDENCE HAS BEEN FOUND IN DHR REVIEW, AND RETAINED SAMPLES EVALUATED MEET ISO7886 ANNEX D, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD PLASTIPAK¿ SYRINGE THERE WAS LEAKAGE BETWEEN THE PLUNGER AND SYRINGE-WALL.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 DURING USE OF THE BD PLASTIPAK¿ SYRINGE THERE WAS LEAKAGE BETWEEN THE PLUNGER AND SYRINGE-WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149335 BD PLASTIPAK¿ SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1801251

    Patients

    Seq Age Sex Outcome Treatment
    1 Other