BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS¿ VP SERIES DEHP FREE INFUSION SET

    MDR report key: 17475068 · Received August 7, 2023

    Report

    Report Number
    9616066-2023-01655
    Event Type
    Malfunction
    Date Received
    August 7, 2023
    Date of Event
    July 18, 2023
    Report Date
    August 30, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    37613203019768
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY. NO SAMPLES WERE RECEIVED FOR INVESTIGATION OF IN WHICH THE CUSTOMER HAS REPORTED EXPERIENCING WHITE LINES ON THE DRIP CHAMBER OF 70593 PRODUCTS FROM LOT 1023284, AFTER THE CHAMBER IS SQUEEZED FOR PRIMING. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 1023284 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. STRESS-WHITENING SUCH AS THAT OBSERVED BY THE CUSTOMER, IS A COMMON FEATURE IN MOST PLASTICS. WHEN THE DRIP CHAMBER IS SQUEEZED, THE POLYMERS IN THE PLASTIC COMPRESS. THIS COMPRESSION CHANGES THE WAY IN WHICH LIGHT IS REFLECTED FROM THE PLASTIC, RESULTING IN THE APPEARANCE OF WHITE STRESS MARKS. THIS IS CONSIDERED A COSMETIC DEFECT ONLY, WHICH IS NOT CRITICAL TO THE FUNCTIONALITY OF THE PRODUCT.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. H.3. 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 · 0

    IT WAS REPORTED WHILE USING BD ALARIS¿ VP SERIES DEHP FREE INFUSION SET FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: AT THE TIME OF USE, THIS DEVICE PRESENTED THE FOLLOWING MALFUNCTION: "DURING MY TUBING PURGE WITH THE TREATMENT, THE TUBING CHAMBER CRACKED. IT SEEMED RIGID, AS IF THE PLASTIC HAD HARDENED. THE 2ND TUBING I USED WAS ALSO RIGID, AND A WHITE LINE APPEARED WHEN MY FINGERS EXERTED PRESSURE DURING PURGING (SAME BATCH)". THIS EVENT HAS NOT BEEN REPORTED TO ANSM. THE MEDICAL DEVICE CONCERNED IS AT YOUR DISPOSAL AT (B)(6). (B)(6) FOR A PERIOD OF SIX MONTHS. I WOULD BE GRATEFUL IF YOU COULD SEND ME A COPY OF YOUR CONCLUSIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ALARIS¿ VP SERIES DEHP FREE INFUSION SET FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: AT THE TIME OF USE, THIS DEVICE PRESENTED THE FOLLOWING MALFUNCTION: "DURING MY TUBING PURGE WITH THE TREATMENT, THE TUBING CHAMBER CRACKED. IT SEEMED RIGID, AS IF THE PLASTIC HAD HARDENED. THE 2ND TUBING I USED WAS ALSO RIGID, AND A WHITE LINE APPEARED WHEN MY FINGERS EXERTED PRESSURE DURING PURGING (SAME BATCH)". THIS EVENT HAS NOT BEEN REPORTED TO ANSM. THE MEDICAL DEVICE CONCERNED IS AT YOUR DISPOSAL AT (B)(6). (B)(6) HOSPITAL PHARMACY FOR A PERIOD OF SIX MONTHS. I WOULD BE GRATEFUL IF YOU COULD SEND ME A COPY OF YOUR CONCLUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284217 BD ALARIS¿ VP SERIES DEHP FREE INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 1023284 37613203019768

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown