BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL TIP BULK CONVENIENCE PAK

    MDR report key: 20261271 · Received September 19, 2024

    Report

    Report Number
    9610847-2024-00273
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    August 28, 2024
    Report Date
    November 6, 2024
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903097037
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 309703 AND LOT NUMBER 2355804&3023355. 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 5ML LL TIP BULK CONVENIENCE PAK HAD FOREIGN MATTER IT WAS REPORTED BY CUSTOMER THAT A FIBER, SUSPECTED HAIR IN CAP OF SYRINGE. THE HAIR WAS DISCOVERED UNDERNEATH THE CAP OF THE FILLED SYRINGES. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. CAN YOU PLEASE HELP US INITIATE A NEW COMPLAINT FOR A 5ML SYRINGE LUER LOCK TRAY PACK WITH MFG. # 309703, IMPACTING LOT #2355804 & #3023355. WE HAVE SAMPLES AVAILABLE FOR RETURN. A FIBER, SUSPECTED HAIR IN CAP OF SYRINGE. THE HAIR WAS DISCOVERED UNDERNEATH THE CAP OF THE FILLED SYRINGES. ALL TRAY PACKS ARE SEALED UNTIL THEY ARE RELEASE TO PRODUCTION, THIS INDICATES THAT THE HAIR ORIGINATED FROM THE VENDOR SEALED PACKAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2330617 BD SYRINGE 5ML LL TIP BULK CONVENIENCE PAK SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 3023355 30382903097037

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown