BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL S/C 200

    MDR report key: 20732999 · Received November 20, 2024

    Report

    Report Number
    1213809-2024-00858
    Event Type
    Malfunction
    Date Received
    November 20, 2024
    Date of Event
    September 18, 2024
    Report Date
    January 25, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    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

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

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302995 AND POTENTIAL LOT NUMBERS 4171566 AND 4101945. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) PHYSICAL SAMPLE WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE SYRINGE, A SIGNIFICANT CRACK WAS OBSERVED ON THE ROOF OF THE BARREL COMPONENT, EXTENDING DOWN TO THE NUMBER SEVEN (7) ON THE NON-SCALE MARKING AREA. THE CRACKED BARREL MOST LIKELY RESULTED DURING THE ASSEMBLY PROCESS. BASED ON TRACKING AND TRENDING, THE OBSERVED DEFECT WAS AN ISOLATED INCIDENT WITH A LOW FREQUENCY OF OCCURRENCE. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    MATERIAL # 302995, BATCH # UNKNOWN. IT WAS REPORTED THAT THE BD SYRINGE 10ML LL S/C 200 BARREL CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. RAPID SEQUENCE INTUBATION FOR AN ICU PATIENT. ROCURONIUM 100MG/10ML WAS DRAWN UP IN A B-D 10ML SYRINGE WITH NO ISSUES. AT TIME OF ADMINISTRATION, IT WAS NOTED THAT THE CONTENTS WERE LEAKING FROM THE SIDE OF THE SYRINGE AND THE FULL DOSE WAS NOT ABLE TO BE GIVEN VIA IV. THIS LED TO AN SITUATION WHERE ANOTHER SYRINGE OF ROCURONIUM HAD TO BE DRAWN UP EMERGENTLY AND LED TO A DELAY IN THERAPY AND WASTED TIME DURING RSI INDUCTION AND DELAY IN INTUBATION. AFTER THE RSI, IT WAS DISCOVERED THE SYRINGE HAD A LARGE CRACK EXTENDING FROM THE TIP TO THE 7ML MARK THAT HAD BEEN COVERED BY THE MEDICATION LABEL. MANUFACTURER CODE/MODEL: 302995. SERIAL OR LOT NUMBER:(B)(6).

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2007805 BD SYRINGE 10ML LL S/C 200 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown