BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE VENTED NOKOR 18X1 TW

    MDR report key: 18282611 · Received December 7, 2023

    Report

    Report Number
    1911916-2023-00876
    Event Type
    Malfunction
    Date Received
    December 7, 2023
    Date of Event
    November 20, 2023
    Report Date
    January 3, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    GAA
    UDI-DI
    00382903052141
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP. IT WAS REPORTED THE NEEDLE WAS CAUSING CORING IN VIALS. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR INVESTIGATION BY OUR QUALITY TEAM. THE PHOTO SHOWS THE MAGNIFICATION OF A NOKOR NEEDLE TIP. NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305214, LOT 3173341. 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 COULD NOT BE CONFIRMED. WITHOUT THE ACTUAL PHYSICAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Additional Manufacturer Narrative · 0

    PR (B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE PROBLEM CODE: A0202 - DEFECTIVE COMPONENT. PATIENT PROBLEM CODE: F27 ¿ NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. MATERIALS#: 305214, BATCH#: 317334.1 IT WAS REPORTED BY THE CUSTOMER THAT THE NOKOR NON-CORING VENTED NEEDLE IS CLASSIFIED AS A BLUNT FILL NEEDLE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. QUESTION: CALLER STATES THEY USE THE NOKOR NON-CORING VENTED NEEDLE 305214. CALLER WAS ASKING IF THERE ARE ANYINSTRUCTIONS FOR HOW TO USE THE NOKOR NEEDLES. CALLER STATES THEY RECENTLY PURCHASED THESE TO HELP ELIMINATECORING IN THEIR VIALS. THEY USED THE NOKOR NEEDLE THIS MORNING AND ENDED UP HAVING CORING IN A THIRD OF THEIRVIALS LEADING TO STOPPER MATERIAL IN THE VIALS. CALLER PROVIDED THE LOT NUMBER 3173341. CALLER ALSO ASKING FOR ACOPY OF THE COA. RESPONSE: INFORMED CALLER THE NOKOR NON-CORING VENTED NEEDLE IS CLASSIFIED AS A BLUNT FILL NEEDLE. PRODUCT CODE 305214IS VENTED, MEANING IT HAS A SIDE PORT TO HELP VENT AND REDUCE VIAL PRESSURE. EMAILED THE BLUNT FILL USAGEGUIDELINES FOR REFERENCE. INFORMED CALLER I WILL SUBMIT THIS TO OUR PRODUCT COMPLAINTS TEAM FOR FURTHERINVESTIGATION. INFORMED CALLER THE COA CAN BE LOCATED ON THE BD REGULATORY SITE. PRODUCT/MODELNUMBER: 305214.

    Description of Event or Problem · 0

    MATERIALS#: 305214 BATCH#: 3173341 IT WAS REPORTED BY THE CUSTOMER THAT THE NOKOR NON-CORING VENTED NEEDLE IS CLASSIFIED AS A BLUNT FILL NEEDLE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. QUESTION CALLER STATES THEY USE THE NOKOR NON-CORING VENTED NEEDLE 305214. CALLER WAS ASKING IF THERE ARE ANYINSTRUCTIONS FOR HOW TO USE THE NOKOR NEEDLES. CALLER STATES THEY RECENTLY PURCHASED THESE TO HELP ELIMINATECORING IN THEIR VIALS. THEY USED THE NOKOR NEEDLE THIS MORNING AND ENDED UP HAVING CORING IN A THIRD OF THEIRVIALS LEADING TO STOPPER MATERIAL IN THE VIALS. CALLER PROVIDED THE LOT NUMBER 3173341. CALLER ALSO ASKING FOR ACOPY OF THE COA. RESPONSE INFORMED CALLER THE NOKOR NON-CORING VENTED NEEDLE IS CLASSIFIED AS A BLUNT FILL NEEDLE. PRODUCT CODE 305214IS VENTED, MEANING IT HAS A SIDE PORT TO HELP VENT AND REDUCE VIAL PRESSURE. EMAILED THE BLUNT FILL USAGEGUIDELINES FOR REFERENCE. INFORMED CALLER I WILL SUBMIT THIS TO OUR PRODUCT COMPLAINTS TEAM FOR FURTHERINVESTIGATION. INFORMED CALLER THE COA CAN BE LOCATED ON THE BD REGULATORY SITE PRODUCT/MODELNUMBER: 305214.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759030 NEEDLE VENTED NOKOR 18X1 TW NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BECTON DICKINSON 3173341 00382903052141

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown