BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.4 QT BD¿ NEXT GENERATION PATIENT COLLECTOR

    MDR report key: 15183089 · Received August 8, 2022

    Report

    Report Number
    2243072-2022-01233
    Event Type
    Malfunction
    Date Received
    August 8, 2022
    Date of Event
    July 12, 2022
    Report Date
    August 18, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903055173
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. (B)(4). MEDICAL DEVICE EXPIRATION DATE: NA.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BASED ON THIS INVESTIGATION, THERE WAS NO EVIDENCE RECEIVED SHOWING THE LACK OF LABEL REPORTED, HOWEVER, WITHIN THE ISSUE DESCRIPTION IT¿S MENTIONED THAT DURING THE INSPECTION AT THE DISTRIBUTOR¿S SIDE BEFORE DELIVERY TO A CUSTOMER, IT WAS FOUND THAT THERE WAS NO LABEL ONTO THE BASE, ALSO, WITH THE LOT NUMBER PROVIDED (1317906) WE WERE ABLE TO CONFIRM THIS PRODUCT WAS MANUFACTURED BY FLEX ON NOVEMBER, 2021. WITH THIS INFORMATION, WE CAN IDENTIFY THIS ISSUE AS A FAILURE MODE RELATED TO THE MANUFACTURING PROCESS. DUE TO THIS FAILURE MODE HAD ALREADY BEEN DETECTED WITHIN INTERNAL NON-CONFORMANCES FOR SIMILAR PROCESSES, IMPROVEMENT OPPORTUNITIES WERE IDENTIFIED TO REINFORCE AND MAKE MORE ROBUST THE LABELING PROCESSES WHICH ARE DOCUMENTED IN THE CAPA RECORD CAR-JRZ-00000392 AND PAR-JRZ-00000170.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 8 5.4 QT BD¿ NEXT GENERATION PATIENT COLLECTOR HAD NO LABEL ON THE BASE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT A MISSING LABEL OF SHARPS COLLECTOR. DURING THE INSPECTION AT THE DISTRIBUTOR'S SIDE BEFORE DELIVERY TO A CUSTOMER, IT WAS FOUND THAT THERE WAS NO LABEL ONTO THE BASE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 8 5.4 QT BD¿ NEXT GENERATION PATIENT COLLECTOR HAD NO LABEL ON THE BASE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT A MISSING LABEL OF SHARPS COLLECTOR. DURING THE INSPECTION AT THE DISTRIBUTOR'S SIDE BEFORE DELIVERY TO A CUSTOMER, IT WAS FOUND THAT THERE WAS NO LABEL ONTO THE BASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2245418 5.4 QT BD¿ NEXT GENERATION PATIENT COLLECTOR HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 305517 1317906 00382903055173

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown