BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGES

    MDR report key: 17061579 · Received June 5, 2023

    Report

    Report Number
    3003152976-2023-00214
    Event Type
    Malfunction
    Date Received
    June 5, 2023
    Date of Event
    May 15, 2023
    Report Date
    September 21, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903008650
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: PHOTOS RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL EVALUATION, LEAKAGE PAST STOPPER IS OBSERVED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2110093, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. NO DAMAGE OR OTHER DEFECTS WAS OBSERVED ON ANY OF THE PRODUCT. LEAKAGE TESTING WAS PERFORMED, NO LEAK OBSERVED. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME. 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 BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    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 PLASTIPAK¿ SYRINGES LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: MEDICATION LEAKAGE WAS DETECTED BETWEEN THE PLUNGER AND THE BODY OF THE SYRINGE. THESE SYRINGES ARE USED TO LOAD CYTOSTATICS AND DURING THEIR USE THEY NOTICED THAT THE MEDICATION WAS LEAKING BETWEEN THE PLUNGER AND THE BODY OF THE SYRINGE. DURING USE. WE HAVE BEEN TALKING FOR ABOUT 3 WEEKS THE NURSING STAFF OF THE SERVICE HAVE BEEN DETECTING FAILURES IN THE 50 ML SYRINGES WITH REF: 300865, THE BATCH WE ARE USING RIGHT NOW IS THE 2110093, IT IS IMPOSSIBLE FOR ME TO KNOW IF THIS INCIDENT HAS BEEN DETECTED IN ANY OTHER BATCH. AS I TOLD YOU, THESE SYRINGES ARE USED TO LOAD CYTOSTATICS AND MEDICATION LEAKAGE HAS BEEN DETECTED BETWEEN THE PLUNGER AND THE BODY OF THE SYRINGE. IT IS A LITTLE COMPLICATED TO TELL YOU THE PERCENTAGE OF DEFECTIVE SYRINGES, BUT APPROXIMATELY 2-3 OUT OF 10. I SENT YOU AN IMAGE WHERE YOU CAN SEE TRACES OF THE MEDICATION. FOR ANY OTHER CLARIFICATION YOU MAY NEED, YOU CAN DO IT EITHER THROUGH THIS EMAIL OR BY CALLING 928-862101. GREETINGS.".

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PLASTIPAK¿ SYRINGES LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: MEDICATION LEAKAGE WAS DETECTED BETWEEN THE PLUNGER AND THE BODY OF THE SYRINGE. THESE SYRINGES ARE USED TO LOAD CYTOSTATICS AND DURING THEIR USE THEY NOTICED THAT THE MEDICATION WAS LEAKING BETWEEN THE PLUNGER AND THE BODY OF THE SYRINGE. DURING USE. WE HAVE BEEN TALKING FOR ABOUT 3 WEEKS THE NURSING STAFF OF THE SERVICE HAVE BEEN DETECTING FAILURES IN THE 50 ML SYRINGES WITH REF: 300865, THE BATCH WE ARE USING RIGHT NOW IS THE 2110093, IT IS IMPOSSIBLE FOR ME TO KNOW IF THIS INCIDENT HAS BEEN DETECTED IN ANY OTHER BATCH. AS I TOLD YOU, THESE SYRINGES ARE USED TO LOAD CYTOSTATICS AND MEDICATION LEAKAGE HAS BEEN DETECTED BETWEEN THE PLUNGER AND THE BODY OF THE SYRINGE. IT IS A LITTLE COMPLICATED TO TELL YOU THE PERCENTAGE OF DEFECTIVE SYRINGES, BUT APPROXIMATELY 2-3 OUT OF 10. I SENT YOU AN IMAGE WHERE YOU CAN SEE TRACES OF THE MEDICATION. FOR ANY OTHER CLARIFICATION YOU MAY NEED, YOU CAN DO IT EITHER THROUGH THIS EMAIL OR BY CALLING (B)(6). GREETINGS.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2324197 BD PLASTIPAK¿ SYRINGES PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2110093 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown