BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL S/C 200

    MDR report key: 20605111 · Received November 4, 2024

    Report

    Report Number
    1213809-2024-00788
    Event Type
    Malfunction
    Date Received
    November 4, 2024
    Date of Event
    October 14, 2024
    Report Date
    January 22, 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
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR 10957953 FOLLOW UP. IT WAS REPORTED THE SYRINGES HAVE A CRACK. TO AID IN THE INVESTIGATION ONE SAMPLE AND ONE PHOTO OF A 10ML LUER LOK SYRINGE WAS RECEIVED AND EVALUATED BY OUR QUALITY TEAM. THE PHOTO SHOWS AN OPENED 10ML PACKAGE WITH ALL APPLICABLE INFORMATION NEXT TO A FULLY ASSEMBLED LOOSE SAMPLE. THE SAMPLE HAS A CRACK EXTENDING FROM THE ROOF OF THE BARREL DOWNWARDS. THE DEFECTS OBSERVED IN THE PHOTOS WERE CONFIRMED IN THE SAMPLE EVALUATION. THIS CONDITION IS NON-CONFORMING PER PRODUCT SPECIFICATION AND IS ASSOCIATED WITH THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302995, LOT 4192194. THE REVIEW REVEALED ALL VISUAL INSPECTIONS WERE PERFORMED PER REQUIREMENTS WITH NO QUALITY NOTIFICATIONS RELATED TO THE DEFECT REPORTED. THE LOT WAS INSPECTED AND ACCEPTED BASED ON OUR INSPECTION CONTROL PLAN AND APPROVED FOR SHIPMENT. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED

    Description of Event or Problem · 0

    MATERIAL #: 302995; BATCH#: 4192194. IT WAS REPORTED THAT THE BD SYRINGE 10ML LL S/C 200 BARREL WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. OUR CLINICAL STAFF ALERTED US TO A CONCERN WITH 10ML LUER LOCK BD SYRINGES. MFG NUMBER 302995. THE SYRINGES HAVE A CRACK IN THEM AS SEEN IN THE ATTACHED IMAGE. LOT NUMBER IS 4192194. CAN YOU FOLLOW UP ON THIS AND CONFIRM IF WE NEED TO DISPOSE OF ALL PRODUCTS WITH THE SAME LOT NUMBER? ADDITIONAL INFORMATION PROVIDED: HERE IS THE FEEDBACK FROM OUR CLINICAL STAFF WHO USED THE IMPACTED SYRINGE. 1. THERE WAS NO IMPACT TO ANY PATIENTS. THE DAMAGE WAS FOUND BEFORE IT AFFECTED ANY COMPOUND THAT REACHED A PATIENT. 2. IT DID NOT HAPPEN DURING PATIENT USE. THE DAMAGE WAS FOUND DURING COMPOUNDING IN THE PHARMACY. NO PRODUCT AFFECTED REACHED A PATIENT. 3. RETURN LABEL CAN BE SENT TO (B)(6). SO FAR, WE HAVE NOT FOUND ANY MORE CRACKED SYRINGES IN THAT LOT. I SUSPECT THAT THOSE WERE ABERRATIONS, NOT A LARGER PROBLEM WITHIN THAT BATCH, BUT WE WILL CONTINUE TO KEEP AN EYE OUT FOR ANYMORE AND TELL YOU IF WE FIND ANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1611962 BD SYRINGE 10ML LL S/C 200 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4192194 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown