BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL

    MDR report key: 17894827 · Received October 9, 2023

    Report

    Report Number
    1911916-2023-00750
    Event Type
    Malfunction
    Date Received
    October 9, 2023
    Date of Event
    September 18, 2023
    Report Date
    October 12, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    NGT
    UDI-DI
    30382903065470
    PMA / PMN Number
    K003553
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE PROBLEM CODE: A0509 - PHYSICAL RESISTANCE / STICKING (2578/1597). PATIENT PROBLEM CODE: F26 - NO HEALTH CONSEQUENCES OR IMPACT.

    Additional Manufacturer Narrative · 0

    PR 9021265 FOLLOW UP REPORT: IT WAS REPORTED THE PLUNGER WAS STUCK AND UNABLE TO PUSH THE SALINE. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A PREFILLED SYRINGE WITH NO PACKAGING FLOW WRAP AND ABOUT 4ML OF SOLUTION. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTO. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306547, LOT 3207548. 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. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WITHOUT THE PHYSICAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Description of Event or Problem · 0

    MATERIAL #: 306547 . BATCH #: 3207548. IT WAS REPORTED BY CUSTOMER THAT THE PLUNGER HAS BEEN STUCK AND UNABLE TO PUSH THE SALINE. VERBATIM: RCC RECEIVED THE COMPLAINT VIA EMAIL. EMAIL(S) AS ATTACHED. LOT # 3207548 10ML SALINE PREFILLED SYRINGES. THE PLUNGER HAS BEEN STUCK AND UNABLE TO PUSH THE SALINE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. MATERIAL #: 306547; BATCH #: 3207548. IT WAS REPORTED BY CUSTOMER THAT THE PLUNGER HAS BEEN STUCK AND UNABLE TO PUSH THE SALINE. VERBATIM: RCC RECEIVED THE COMPLAINT VIA EMAIL. EMAIL(S) AS ATTACHED. LOT # 3207548 10ML SALINE PREFILLED SYRINGES. THE PLUNGER HAS BEEN STUCK AND UNABLE TO PUSH THE SALINE. RESPONSE RECEIVED 06 OCT 2023: ARE YOU ABLE TO PROVIDE THE DATE OF THE EVENT IN THE FORMAT OF DD-MM-YYYY? 09/18/2023- HOW WAS THE PATIENT OUTCOME? ARE THERE ANY CLINICAL SIGNS, HEALTH CONSEQUENCES OR IMPACT? DID THE EVENT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION? NO. DID THE EVENT CAUSE PERMANENT IMPAIRMENT OF A BODY FUNCTION? DID THE EVENT REQUIRE MEDICAL OR SURGICAL INTERVENTION? NO. DID THE EVENT CAUSE PERMANENT DAMAGE OF A BODY STRUCTURE? NO. ANY SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1711186 SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL SALINE, VASCULAR ACCESS FLUSH NGT BECTON DICKINSON 3207548 30382903065470

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown