BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOCK¿ SYRINGE

    MDR report key: 17814275 · Received September 25, 2023

    Report

    Report Number
    9614033-2023-00115
    Event Type
    Malfunction
    Date Received
    September 25, 2023
    Date of Event
    August 26, 2023
    Report Date
    October 27, 2023
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMI
    UDI-DI
    07501073025622
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHOTOS RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, POORLY ASSEMBLES STOPPER AND DAMAGED LUER TIP OF SYRINGE IS OBSERVED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON OUR INVESTIGATION, POSSIBLE ROOT CAUSE FOR POORLY ASSEMBLED STOPPER IS ASSOCIATED WITH TRANSFER DISC DIALS, REPLACEMENT OF THE DIAL OF THE TRANSFER DISC WILL BE EXECUTED. POSSIBLE ROOT CAUSE FOR LUER DAMAGE IS ASSOCIATED WITH ADJUSTMENT FAILURE IN THE NOZZLE. INSPECTION AND CHANGE OF THE NOZZLE WILL BE IMPLEMENTED.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. INCIDENT 1: WHEN OPENING THE PACKAGING TO USE THE SYRINGE, NURSING STAFF NOTICE THAT A PART OF THE RUBBER PISTON APPEARS MELTED, WHICH IS WHY IT CANNOT BE USED. ¿ PRODUCT LOT: 2098104 ¿ AMOUNT AFFECTED: 1 SYRINGE ¿ DATE OF INCIDENT: (B)(6) 2023 _____ INCIDENT 2: WHEN OPENING THE PACKAGE TO USE THE SYRINGE, NURSING STAFF NOTICE THAT A PART OF THE PIVOT APPEARS MELTED, WHICH IS WHY IT CANNOT BE USED. ¿ PRODUCT LOT: 2161844 ¿ AMOUNT AFFECTED: 1 SYRINGE ¿ DATE OF INCIDENT: (B)(6) 2023 ____ INCIDENT 3: WHEN OPENING THE PACKAGING TO USE THE SYRINGE, NURSING STAFF NOTICE THAT A PART OF THE PIVOT APPEARS MELTED, WHICH IS WHY IT CANNOT BE USED. ¿ PRODUCT LOT: 2161845 ¿ AMOUNT AFFECTED: 1 SYRINGE ¿ DATE OF INCIDENT: (B)(6) 2023 ____ ADDITIONAL INFORMATION REGARDING THE 3 INCIDENTS ¿ WAS THERE A PATIENT INVOLVED? NO ¿ WAS THE PROBLEM IDENTIFIED BEFORE, DURING OR AFTER USE? BEFORE ITS USE. ¿ WAS THERE AN IMPACT ON THE PATIENT OR HEALTH PROFESSIONAL? (DETAIL) NO, IT WAS DETECTED BEFORE REACHING THE PATIENT. ¿ WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION DUE TO WHAT OCCURRED (IMAGING EXAMINATIONS, SURGERY, MEDICATION ADMINISTRATION, ETC.)? (DETAIL) NO ¿ HAS THERE BEEN EXPOSURE OF BLOOD OR CHEMOTHERAPY TO THE MUCOUS MEMBRANES OR SKIN? (DETAIL) NO ¿ IS THE SAMPLE RELATED (THE PRODUCT) TO THE INCIDENT AVAILABLE FOR ANALYSIS? YES ¿ COULD YOU SEND PHOTOS OF THE PRODUCT TO SHOW THE CATALOGUE, BATCH AND DEFECT? YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PART OF THE BD LUER-LOCK¿ SYRINGE BARREL APPEARED MELTED WHEN REMOVING IT FROM THE PACKAGING. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "INCIDENT 2: WHEN OPENING THE PACKAGE TO USE THE SYRINGE, NURSING STAFF NOTICE THAT A PART OF THE PIVOT APPEARS MELTED, WHICH IS WHY IT CANNOT BE USED. PRODUCT LOT: 2161844 AMOUNT AFFECTED: 1 SYRINGE. DATE OF INCIDENT: JULY 26, 2023. ADDITIONAL INFORMATION REGARDING THE 3 INCIDENTS WAS THERE A PATIENT INVOLVED? NO. WAS THE PROBLEM IDENTIFIED BEFORE, DURING OR AFTER USE? BEFORE ITS USE. WAS THERE AN IMPACT ON THE PATIENT OR HEALTH PROFESSIONAL? (DETAIL) NO, IT WAS DETECTED BEFORE REACHING THE PATIENT. WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION DUE TO WHAT OCCURRED (IMAGING EXAMINATIONS, SURGERY, MEDICATION ADMINISTRATION, ETC.)? (DETAIL) NO ¿ HAS THERE BEEN EXPOSURE OF BLOOD OR CHEMOTHERAPY TO THE MUCOUS MEMBRANES OR SKIN? (DETAIL) NO".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1096344 BD LUER-LOCK¿ SYRINGE PISTON SYRINGE FMI BECTON DICKINSON DE MEXICO 2161844 07501073025622
    2091907 BD LUER-LOCK¿ SYRINGE PISTON SYRINGE FMI BECTON DICKINSON DE MEXICO 2161844 07501073025622

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown