BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE CATHETER TIP 50ML

    MDR report key: 23756295 · Received December 9, 2025

    Report

    Report Number
    1911916-2025-00782
    Event Type
    Malfunction
    Date Received
    December 9, 2025
    Date of Event
    November 19, 2025
    Report Date
    December 13, 2025
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    KYZ
    UDI-DI
    00382903096206
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THAT A DOMINANT BLACK TAPE WAS PRESENT ON THE ITEM PACKAGING, AND THE SYRINGES WITH THIS TAPE WERE NOT SEALED PROPERLY. TO SUPPORT THE INVESTIGATION, FOUR SAMPLES AND TWO PHOTOGRAPHS WERE PROVIDED FOR EVALUATION BY THE QUALITY TEAM. THREE SAMPLES WERE IN SEALED PACKAGING BLISTERS, WHILE ONE SAMPLE WAS IN AN OPENED BLISTER. A VISUAL INSPECTION REVEALED THAT THE TOP WEBS OF THE PACKAGING BLISTERS HAD DARK-COLORED TAPE APPLIED TO BOTH SIDES. THE PHOTOGRAPHS CORRESPOND TO THE SAMPLES RECEIVED. NO ADDITIONAL DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS CONDITION MAY OCCUR DURING THE SPLICING OF TWO TOP WEB ROLLS IF THE AFFECTED UNITS WERE NOT REMOVED FROM THE PRODUCTION FLOW. A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR MATERIAL NUMBER 309620, LOT 5171908. THE REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION, NOR WERE THERE ANY RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. THE SAMPLES WILL BE SHARED WITH ASSOCIATES FOR AWARENESS. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND ANALYSIS OF THE RETURNED SAMPLES, THE CUSTOMER¿S REPORTED CONDITION HAS BEEN CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE CATHETER TIP 50ML PACKAGE WAS DAMAGED / DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED 50 ML SYRINGE CATHETER TIP REF (B)(4). LOT 5121908 ISSUE: THERE IS A DOMINANT BLACK TAPE OVER THE ITEM PACKAGING AND THE SYRINGES WITH THIS TYPE OF TAPE ARE NOT SEALED PROPERLY. THIS ITEM COULD NOT BE USED TO DUE TO CONCERN OF QUALITY, CLEANLINESS, AND PATIENT SAFETY. IT WAS WITHIN THE SAME PACKAGE OF OTHERS AND OTHER SYRINGES IN THE SAME BOX DID NOT LOOK DIRTY OR AFFECTED. ADDITIONAL INFORMATION PROVIDED: FOR (B)(4). I WAS GIVEN THE ITEM ON 11/04/2025. 2. CORRECT LOT # 5171908 3. THERE WAS NO DAMAGE TO THE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2114145 BD SYRINGE CATHETER TIP 50ML SYRINGE, IRRIGATING (NON DENTAL) KYZ BD MEDICAL (BD WEST) MEDICAL SURGICAL 5171908 00382903096206

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown