BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ INJECTOR LUER LOCK N35C

    MDR report key: 7356088 · Received March 20, 2018

    Report

    Report Number
    3003152976-2018-00101
    Event Type
    Malfunction
    Date Received
    March 20, 2018
    Date of Event
    February 23, 2018
    Report Date
    March 21, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONG
    UDI-DI
    30382905150044
    PMA / PMN Number
    K123213
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1712001. MEDICAL DEVICE EXPIRATION DATE: 2020-05-31. DEVICE MANUFACTURE DATE: 2017-12-27. MEDICAL DEVICE LOT #: 1709003. MEDICAL DEVICE EXPIRATION DATE: 2020-02-29. DEVICE MANUFACTURE DATE: 2017-10-16. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: CUSTOMER COMPLAINTS ABOUT LEAK AFTER 48 HOURS OF KEEPING THE INJECTOR TOGETHER WITH THE SYRINGES IN THE FRIDGE. SOME PICTURES WERE RECEIVED. SOME SAMPLES WERE RECEIVED AS WELL (3 UNUSED SAMPLES OF LOT#1712001; NO SAMPLES OF LOT 1#709003). 3 RETAINED SAMPLES OF LOT#1709003 WERE EVALUATED. NO LEAK IS FOUND IN PICTURES RECEIVED. IT IS NO POSSIBLE TO SEE ANY DROP WHICH MAY INDICATE THAT A LEAK OCCURRED. IN THE PICTURES, AS THE CAP IS ATTACHED TO THE INJECTOR, IT IS NO POSSIBLE TO SEE THE APPEARANCE OF THE MEMBRANE. ONE SAMPLE OF EACH LOT WAS USED TO REPRODUCE THE CUSTOMER'S EXPERIENCE: EACH INJECTOR WAS ATTACHED TO A 50 ML PLASTIPAK SYRINGE, AND SOME COLORED LIQUID WAS TAKEN FROM A VIAL USING A PROTECTOR. IT MEANS THAT THE MEMBRANE OF EACH INJECTOR WAS ONLY ONCE PICTURED. BOTH SYRINGES+INJECTOR WERE KEPT IN THE FRIDGE FOR 48 HOURS. (09.00H 19/MAR/2018 TO 09.00H 21/MAR/2018). AFTER THAT PERIOD OF TIME, NO LEAK WAS FOUND IN ANY PART OF THE INJECTOR. IN THE OTHER HAND, 2 SAMPLES OF EACH LOT WERE USED TO THE PERFORM THE POSITIVE PRESSURE TEST. THE RESULTS HAVE BEEN ACCEPTABLE. NO NON-CONFORMANCES WERE FOUND DURING MANUFACTURING PROCESS. PLEASE, TAKE INTO ACCOUNT THAT, AS IT IS EXPLAINED IN THE IFU "THE PERFORMANCE OF THE SEALING MEMBRANE IS REDUCE AFTER MULTIPLE PERFORATIONS AND EXTENDED ACTIVATION TIME). INVESTIGATION CONCLUSION: THE DEFECT CANNOT BE CONFIRMED UPON THE RECEIVED PICTURES AND THE EXPERIENCE PERFORMED WITH THE RETAINED&RECEIVED SAMPLES. NO NON-CONFORMANCES WERE FOUND DURING MANUFACTURING PROCESS (NO QN'S OR OTHER ISSUES IN LOTS#1709003 (ASSEMBLY LOT 7265359) AND LOT#1712001 (ASSEMBLY LOT7331856). PLEASE, TAKE INTO ACCOUNT THAT, AS IT IS EXPLAINED IN THE IFU (DGP100) "THE PERFORMANCE OF THE SEALING MEMBRANE IS REDUCE AFTER MULTIPLE PERFORATIONS AND EXTENDED ACTIVATION TIME).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN STORING A BD PHASEAL¿ INJECTOR LUER LOCK N35C (CONNECTED TO A PASTIPAK SYRINGE) IN THE REFRIGERATOR FOR TWO DAYS, THERE WAS PRESENCE OF CHEMOTHERAPY DROPS IN THE CAP, SHOWING THE LACK OF WATERTIGHT SEAL OF THE SYSTEM. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194758 BD PHASEAL¿ INJECTOR LUER LOCK N35C INJECTOR ONG BECTON DICKINSON, S.A. SEE H.10 30382905150044

    Patients

    Seq Age Sex Outcome Treatment
    1 Other