BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE CATHETER TIP 50ML

    MDR report key: 20389256 · Received October 7, 2024

    Report

    Report Number
    1911916-2024-00718
    Event Type
    Malfunction
    Date Received
    October 7, 2024
    Date of Event
    October 1, 2024
    Report Date
    October 22, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    KYZ
    UDI-DI
    30382903096207
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP. IT WAS REPORTED THE CAP HAS A BROWN SEDIMENT. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, FOUR PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. TWO PHOTOS SHOW A SYRINGE WITH THE TIP CAP THAT HAS BROWN COLORED SPECKS. ONE PHOTO SHOWS THE INNER SIDE OF THE TIP CAP CONFIRMING THE SPECKS ARE IN THE CAP. FROM THESE PHOTOS, IT IS NOT CLEAR IF THE SPECKS ARE EMBEDDED. THE FOURTH PHOTO SHOWS A PACKAGING BLISTER TOP WEB. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309620, LOT 4172751. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. WITHOUT THE ACTUAL PHYSICAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Description of Event or Problem · 0

    MATERIAL # 309620 BATCH # 4172751 IT WAS REPORTED BY CUSTOMER THAT BD 50 ML SYRINGE WITH A CATHETER TIP. INSIDE THE CAP HAS BROWN SEDIMENT. VERBATIM: I WANTED TO BRING TO YOUR ATTENTION TWO ITEMS FOUND IN 3 MAIN¿S CLEAN UTILITY ROOM. THE FIRST IS A BD 50 ML SYRINGE WITH A CATHETER TIP. INSIDE THE CAP HAS BROWN SEDIMENT. PICTURES ARE INCLUDED BELOW. THE NURSE WAS OPENING UP THE PACKAGE, WHICH WAS SEALED, AND FOUND THE CAP TO BE CONTAMINATED. THE SECOND ITEM IS A LUER LOCK SYRINGE PACKED OUT ON SHELVES IN NO PACKAGING OR IN ANY BAG. THESE SYRINGES ARE USED FOR FEEDING TUBES, AND PACKED OUT WITH NO COVERING THEY ARE EXPOSED TO POTENTIAL DUST OR CONTAMINANTS. I HAVE INCLUDED PICTURES OF BOTH PRODUCTS AS WELL AS THE PACKAGING FOR THE BD SYRINGE WITH THE LOT NUMBER. THANK YOU,

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. MATERIAL # 309620; BATCH # 4172751. IT WAS REPORTED BY CUSTOMER THAT BD 50 ML SYRINGE WITH A CATHETER TIP. INSIDE THE CAP HAS BROWN SEDIMENT. VERBATIM: I WANTED TO BRING TO YOUR ATTENTION TWO ITEMS FOUND IN 3 MAIN¿S CLEAN UTILITY ROOM. THE FIRST IS A BD 50 ML SYRINGE WITH A CATHETER TIP. INSIDE THE CAP HAS BROWN SEDIMENT. PICTURES ARE INCLUDED BELOW. THE NURSE WAS OPENING UP THE PACKAGE, WHICH WAS SEALED, AND FOUND THE CAP TO BE CONTAMINATED. THE SECOND ITEM IS A LUER LOCK SYRINGE PACKED OUT ON SHELVES IN NO PACKAGING OR IN ANY BAG. THESE SYRINGES ARE USED FOR FEEDING TUBES AND PACKED OUT WITH NO COVERING THEY ARE EXPOSED TO POTENTIAL DUST OR CONTAMINANTS. I HAVE INCLUDED PICTURES OF BOTH PRODUCTS AS WELL AS THE PACKAGING FOR THE BD SYRINGE WITH THE LOT NUMBER. THANK YOU,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283666 SYRINGE CATHETER TIP 50ML SYRINGE, IRRIGATING (NON DENTAL) KYZ BECTON DICKINSON 4172751 30382903096207

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown