BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NDLE 18GA 1-1/2IN BLT FILL NC TW SHLD

    MDR report key: 19313502 · Received May 14, 2024

    Report

    Report Number
    3002682307-2024-00103
    Event Type
    Malfunction
    Date Received
    May 14, 2024
    Date of Event
    April 18, 2024
    Report Date
    September 10, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FOZ
    UDI-DI
    00382903031290
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DO NOT CANCEL MDR. UPON FURTHER REVIEW, IT WAS DETERMINED THAT THIS COMPLAINT RECORD AND ITS ASSOCIATED MDR REMAINS VALID.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303129 AND LOT NUMBER 230201. 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, TWO (2) PICTURE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PICTURES, A VIAL WITH A GREY PARTICLE INSIDE WAS OBSERVED. IT IS UNDERSTOOD THAT THE GREY PARTICLE WAS FROM THE VIAL STOPPER. AS THE NEEDLE PRODUCT WAS NOT SHOWN OR PROVIDED FOR EXAMINATION, THE IMPACT OF THE NEEDLE CANNOT BE CONFIRMED. TWENTY (20) RETAINED SAMPLES WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR REVIEW. THE RETAINED SAMPLES WERE USED TO PUNCTURE A LABORATORY VIAL AND NO ISSUES WERE IDENTIFIED. AFTER PUNCTURE THE NEEDLES WERE MICROSCOPICALLY EXAMINED AND NO PARTICLES FROM VIAL STOPPER FRAGMENTATION WERE IDENTIFIED AND ALL NEEDLE BEVELS WERE WELL FORMED. BASED ON THE PROVIDED FEEDBACK, WE UNDERSTAND AN ISSUE OF NEEDLE CORING TOOK PLACE. TAKING INTO ACCOUNT THE PREVENTIVE MEASURES AND CONTROLS IN PLACE DURING THE MANUFACTURING PROCESS, IT IS UNLIKELY THAT THE CORING WAS CAUSED BY POOR OR INSUFFICIENT DE-BURRING OF THE CANNULA. THE VIAL STOPPER AND THE TECHNIQUE USED TO PENETRATE THE VIAL MAY HAVE HAD AN IMPLICATION IN THIS EVENT. 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.

    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

    CORRECTION: THIS COMPLAINT RECORD IS CANCELLED DUE TO EVIDENCE THAT IT IS A DUPLICATE COMPLAINT RECORD. IT HAS ALSO BEEN REPORTED AND CAPTURED IN MFR REPORT # 1911916-2024-00311.

    Description of Event or Problem · 0

    THERE HAS BEEN NO KNOWN IMPACT ON THE PATIENT. NO FURTHER ACTION HAS BEEN TAKEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEEDLE 18GA 1-1/2IN BLT FILL NC TW SHLD HAD FOREIGN MATTER I AM WRITING TO YOU DUE TO TWO REPORTED INCIDENTS, WHICH WE SUSPECT ARE RELATED TO THE LOADING NEEDLE " BD¿ BLUNT FILL NEEDLE", THE INCIDENTS ARE DESCRIBED BELOW AND PHOTOGRAPHS ARE ATTACHED: 1.- MEDICATION WITH NATIONAL CODE 728879, WHEN INTRODUCING THE NEEDLE " BD¿ BLUNT FILL NEEDLE" INTO THE VIAL FOR RECONSTITUTION A DETACHED RUBBER PARTICLE IS OBSERVED INSIDE THE VIAL. 2.- EMPTY DEPYROGENATED VIAL, EP SCIENTIFIC SUPPLIER, WHEN PENETRATING THE CONTAINER TO MAKE THE RECONSTITUTION INSIDE THE VIAL, THE NURSE IN CHARGE OF THE PROCESS OBSERVES THAT THERE IS A PARTICLE COMING FROM THE RUBBER INSIDE THE VIAL. EXAMINING THE TECHNICAL DATA SHEET OF THE PRODUCT, IN ITS DESCRIPTION, IT MAKES REFERENCE TO THE FACT THAT THIS SET IS DESIGNED TO AVOID THE RELEASE OF RUBBER PARTICLES INSIDE THE CONTAINER, WHICH IS WHY THIS MANAGEMENT, COMMITTED TO PATIENT SAFETY, HAS ACQUIRED IT. THE DATA OF THE NEEDLES USED: NEEDLE BD¿ BLUNT FILL NEEDLE 18G 1.2 X40MM LOT 230201 CAD 01/2028. DUE TO THE NEED FOR CONTINUITY OF CARE WITH SAFETY FOR BOTH THE PROFESSIONAL AND THE PATIENT, AND THE CONSEQUENCES THAT THESE INCIDENTS COULD HAVE CAUSED, WE WOULD APPRECIATE A PROMPT RESPONSE TO WHAT HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634216 BD NDLE 18GA 1-1/2IN BLT FILL NC TW SHLD INTRAVASCULAR CATHETER FOZ BECTON DICKINSON, S.A. 230201 00382903031290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown