BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL 200 S/C

    MDR report key: 11566166 · Received March 24, 2021

    Report

    Report Number
    1213809-2021-00162
    Event Type
    Malfunction
    Date Received
    March 24, 2021
    Date of Event
    February 26, 2021
    Report Date
    May 11, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096572
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE CORRECTED: D4: MEDICAL DEVICE LOT #: UNKNOWN. D4: MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4: DEVICE MANUFACTURE DATE: UNKNOWN. D10: DEVICE AVAILABLE FOR EVAL: NO. D10: RETURNED TO MANUFACTURER ON: NA. H1: DEVICE RETURN TO MANUF .? NO. H6: INVESTIGATION SUMMARY . SAMPLES WERE SENT FOR INVESTIGATION, HOWEVER SHIPMENT HAS BEEN SUSPENDED OF POTENTIALLY CONTAMINATED SAMPLES DUE TO COVID-19 CONCERNS. THEREFORE, BD WILL NOT BE RECEIVING SAMPLES ON THIS COMPLAINT. SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 3ML LL 200 S/C HAD A CRACK AND LEAKED BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309657 BATCH NO.: 0261826. IT WAS REPORTED THAT THERE WAS A HOLE/CRACK IN THE SYRINGE, CAUSING BLOOD TO SPRAY OUT. PER EMAIL: CONNECTED 3ML SYRINGE TO ECMO PIGTAIL, STOPCOCK TURNED TO DRAW BLOOD INTO SYRINGE, SYRINGE WITH HOLE/CRACK CAUSING BLOOD TO SPRAY ALL OVER EMPLOYEE AND ENVIRONMENT. WAS NOT CONSIDERED AN EXPOSURE AS A BLOOD ONLY GOT ON EMPLOYEES GLOVES, ARM, AND THE FLOOR. THE DEVICE WAS RETAINED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 3ML LL 200 S/C HAD A CRACK AND LEAKED BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309657 BATCH NO.: 0261826 IT WAS REPORTED THAT THERE WAS A HOLD/CRACK IN THE SYRINGE, CAUSING BLOOD TO SPRAY OUT. PER EMAIL: CONNECTED 3ML SYRINGE TO ECMO PIGTAIL, STOPCOCK TURNED TO DRAW BLOOD INTO SYRINGE, SYRINGE WITH HOLE/CRACK CAUSING BLOOD TO SPRAY ALL OVER EMPLOYEE AND ENVIRONMENT. WAS NOT CONSIDERED AN EXPOSURE AS A BLOOD ONLY GOT ON EMPLOYEES GLOVES, ARM, AND THE FLOOR. THE DEVICE WAS RETAINED...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461545 SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 00382903096572

    Patients

    Seq Age Sex Outcome Treatment
    1