BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 20ML LL TIP CONV PAK

    MDR report key: 20665404 · Received November 12, 2024

    Report

    Report Number
    9610847-2024-00349
    Event Type
    Malfunction
    Date Received
    November 12, 2024
    Date of Event
    October 18, 2024
    Report Date
    November 14, 2024
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    00382903056170
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. BATCH # 4120274, 4120268, 4064405.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305617 AND LOT NUMBER 4120274. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 20ML LL TIP CONV PAK LEAKAGE PAST STOPPER. IT WAS REPORTED BY CUSTOMER THAT DRUG LEAKS INTO THE SYRINGE PLUNGER (BETWEEN THE 2 SEALED RUBBER SECTIONS). RCC RECEIVED A COMPLAINT VIA EMAIL. DRUG LEAKS INTO THE SYRINGE PLUNGER (BETWEEN THE 2 SEALED RUBBER SECTIONS). RISK OF MEDICATION BECOMING UNSTERILE (CONTAMINATION BY MICRO-ORGANISMS).WE HAD SEVERAL PROBLEMATIC 20 ML SYRINGE TRAYS WITH BETWEEN 1 AND 5 SYRINGES LEAKING AT THE PLUNGER. THE PROBLEM WAS IDENTIFIED ON AT LEAST 3 DIFFERENT BATCHES BETWEEN JULY AND OCTOBER 2024. WE HAVE LOST SEVERAL DOSES OF MEDICATION IN SEVERAL BATCHES (THE PRODUCT IS NO LONGER CONSIDERED STERILE). *INCIDENT DATE AND AFFECTED QUANTITY UNKNOWN. ADDITIONAL INFORMATION WILL BE SENT VIA SEPARATE EMAIL. CAT# OF PRODUCT BEING COMPLAINED: BD305617. LOT OR S/N: (B)(6).

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1513625 BD SYRINGE 20ML LL TIP CONV PAK SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 4120274 00382903056170

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown