BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL

    MDR report key: 19566246 · Received June 19, 2024

    Report

    Report Number
    1911916-2024-00442
    Event Type
    Malfunction
    Date Received
    June 19, 2024
    Date of Event
    June 7, 2024
    Report Date
    June 24, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    30382903065470
    PMA / PMN Number
    K003553
    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

    PR 10324349 FOLLOW UP . IT WAS REPORTED THE PLUNGER PULLED OUT OF THE BARREL WHEN ASPIRATING. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. IT COULD BE POSSIBLE THE CUSTOMER IS NOT USING THE PRODUCT AS INTENDED. THE PRODUCT IS DESIGNED TO PUSH THE PLUNGER ROD DOWN WHILE FLUSHING THE SALINE SOLUTION. AFTER EXPELLING, THE UNIT SHOULD BE DISCARDED. THE PLUNGER IS NOT DESIGNED TO BE PULLED BACK. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306547, LOT 4080944. 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 NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. 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 MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED. THE ISSUE IS THE GOOD ONES YOU CANNOT TURN OR MOVE THE END PART OF SYRINGE. ON THE BAD ONES WHILE INSIDE THE PACKAGE YOU CAN TURN THE BOTTOM COMPLETELY AROUND WHICH YOU SHOULD NOT BE ABLE TO DO, AND THAT IS WHAT IS CAUSING THE ISSUES ARE THE ONES WITH LOOSE BOTTOMS. THE PLUNGER COMES OUT OF THE BARREL OF THE SYRINGE WHILE ASPIRATING. MATERIAL# 306547. BATCH# 4080944. IT WAS REPORTED BY CUSTOMER THAT THE PLUNGER COMES OUT OF THE BARREL OF THE SYRINGE WHILE ASPIRATING. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THE PLUNGER COMES OUT OF THE BARREL OF THE SYRINGE WHILE ASPIRATING. ITEM -306547. LOT -4080944.

    Description of Event or Problem · 0

    MATERIAL# 306547. BATCH# 4080944. IT WAS REPORTED BY CUSTOMER THAT THE PLUNGER COMES OUT OF THE BARREL OF THE SYRINGE WHILE ASPIRATING. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. THE PLUNGER COMES OUT OF THE BARREL OF THE SYRINGE WHILE ASPIRATING. ITEM -306547. LOT -4080944.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596129 SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL SALINE, VASCULAR ACCESS FLUSH FOZ BECTON DICKINSON INCORRECT ENTRY 30382903065470

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown