BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SHARPS COLLECTOR 8 QT MULTI-USE NESTABLE

    MDR report key: 15183080 · Received August 8, 2022

    Report

    Report Number
    2243072-2022-01232
    Event Type
    Malfunction
    Date Received
    August 8, 2022
    Date of Event
    July 12, 2022
    Report Date
    August 19, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    50382903053433
    PMA / PMN Number
    K943134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. BASED ON THIS INVESTIGATION, THERE WAS NO EVIDENCE RECEIVED SHOWING THE LACK OF LABEL IN THE BASE, HOWEVER, IN THE REPORT IT¿S MENTIONED THAT BIOHAZARD WARNING LABEL WAS MISSING. 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. SINCE NO LOT NUMBER WAS PROVIDED, IT CAN¿T BE CONFIRMED IF THIS PRODUCT WAS MANUFACTURED BEFORE OR AFTER THE CORRECTIVE ACTION¿S IMPLEMENTATION. BASED ON THIS INVESTIGATION AND INFORMATION PROVIDED AS EVIDENCE, IT WAS CONFIRMED THIS ISSUE WAS RELATED TO MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD SHARPS COLLECTORS 8 QT MULTI-USE NESTABLE HAD MISSING BIOHAZARD WARNING LABELS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT MISSING LABELS OF SHARPS COLLECTOR. ACCORDING TO THE CUSTOMER'S REPORT, THE BIOHAZARD WARNING LABEL WAS MISSING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD SHARPS COLLECTORS 8 QT MULTI-USE NESTABLE HAD MISSING BIOHAZARD WARNING LABELS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT MISSING LABELS OF SHARPS COLLECTOR. ACCORDING TO THE CUSTOMER'S REPORT, THE BIOHAZARD WARNING LABEL WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2297593 BD SHARPS COLLECTOR 8 QT MULTI-USE NESTABLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 305343 UNKNOWN 50382903053433

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown