BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL TIP CONV PAK

    MDR report key: 17950839 · Received October 17, 2023

    Report

    Report Number
    1911916-2023-00779
    Event Type
    Malfunction
    Date Received
    October 17, 2023
    Date of Event
    October 12, 2023
    Report Date
    November 22, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903056188
    PMA / PMN Number
    K110771
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OUR QUALITY ENGINEER INSPECTED THE 5 UNPACKAGED SAMPLES SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF LEAKAGE PAST STOPPER WAS NOT CONFIRMED UPON INSPECTION AND TESTING OF THE SAMPLES. ANALYSIS OF THE SAMPLES SHOWED THAT THERE WERE NO DISCERNABLE DAMAGES OR IRREGULARITIES PRESENT. THE SAMPLES ALL UNDERWENT LEAKAGE TESTING, AND ALL PASSED WITH NO SIGNS OF LEAKAGE. BD COULD NOT DETERMINE A MANUFACTURING RELATED ROOT CAUSE SINCE THE REPORTED DEFECT WAS NOT CONFIRMED DURING THE EVALUATION OF THE SAMPLE. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. WE REGRET ANY INCONVENIENCES THIS INCIDENT MAY HAVE CAUSED YOU AND YOUR FACILITY. H3 OTHER TEXT : SEE NARRATIVE BELOW.

    Additional Manufacturer Narrative · 0

    (B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. PATIENT PROBLEM CODE: F26 ¿ NO HEALTH CONSEQUENCES OR IMPACT. DEVICE PROBLEM CODE: A0504 - LEAK / SPLASH.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. MAT#:305618 BATCH#: 3150632. IT WAS REPORTED BY THE CUSTOMER THAT THEY HAD 5 SYRINGES THAT WERE LEAKING THROUGH THE PLUNGER INSIDE THE BARREL (ALL FROM DIFFERENT PACKS BUT ALL THE SAME LOT). VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. REF (B)(4). SYRINGE 30ML LL TIP CONV PAK. LOT 3150632. THEY HAD 5 SYRINGES THAT WERE LEAKING THROUGH THE PLUNGER INSIDE THE BARREL (ALL FROM DIFFERENT PACKS BUT ALL THE SAME LOT). 16 OCT 23. PLEASE ADVISE THE OCCURRENCE DATE. (B)(6) 2023 -IS THERE ANY ADVERSE EVENT ON PATIENT? NO, LEAKING WAS OBSERVED BEFORE THE SYRINGES LEFT THE PHARMACY. IS THERE ANY MEDICAL INTERVENTION NEEDED DUE TO THE INCIDENT? NO. WHAT IS THE DRUG USED DURING THE INCIDENT? CEFEPIME AND CEFTRIAXONE. DO YOU HAVE PHOTO FOR OUR REVIEW? YES. IS SAMPLE AVAILABLE FOR RETURN? IF YES, PLEASE ADVISE YOUR ADDRESS FOR RETURN LABEL. WE HAVE THE 5 SYRINGES THAT HAVE DRUG IN THEM. WE ALSO HAVE 6 PACKS FROM THE SAME LOT THAT HAVE NOT BEEN OPENED.

    Description of Event or Problem · 0

    MAT#:305618 , BATCH#: 3150632. IT WAS REPORTED BY THE CUSTOMER THAT THEY HAD 5 SYRINGES THAT WERE LEAKING THROUGH THE PLUNGER INSIDE THE BARREL (ALL FROM DIFFERENT PACKS BUT ALL THE SAME LOT). VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. REF (B)(4), SYRINGE 30ML LL TIP CONV PAK, LOT 3150632. THEY HAD 5 SYRINGES THAT WERE LEAKING THROUGH THE PLUNGER INSIDE THE BARREL (ALL FROM DIFFERENT PACKS BUT ALL THE SAME LOT). (B)(6) 2023. PLEASE ADVISE THE OCCURRENCE DATE: (B)(6) 2023. IS THERE ANY ADVERSE EVENT ON PATIENT? : NO, LEAKING WAS OBSERVED BEFORE THE SYRINGES LEFT THE PHARMACY. IS THERE ANY MEDICAL INTERVENTION NEEDED DUE TO THE INCIDENT?: NO. WHAT IS THE DRUG USED DURING THE INCIDENT? : CEFEPIME AND CEFTRIAXONE. DO YOU HAVE PHOTO FOR OUR REVIEW?: YES. IS SAMPLE AVAILABLE FOR RETURN? IF YES, PLEASE ADVISE YOUR ADDRESS FOR RETURN LABEL. WE HAVE THE 5 SYRINGES THAT HAVE DRUG IN THEM. WE ALSO HAVE 6 PACKS FROM THE SAME LOT THAT HAVE NOT BEEN OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93601 SYRINGE 30ML LL TIP CONV PAK SYRINGE, PISTON FMF BECTON DICKINSON 3150632 30382903056188

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown