BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 60ML LL TIP 1ML 2 OZ IN 1/4 OZ

    MDR report key: 8430477 · Received March 18, 2019

    Report

    Report Number
    1911916-2019-00279
    Event Type
    Malfunction
    Date Received
    March 18, 2019
    Date of Event
    March 1, 2019
    Report Date
    March 21, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: 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. 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. THIS IS THE 2ND COMPLAINT FOR THE LOT#8270842 FOR THE SAME DEFECTS OR SYMPTOMS. THERE WAS NO DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF LOT # 8270842 DURING THE PRODUCTION RUN. BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SEVEN SYRINGES 60ML LL TIP 1ML 2 OZ IN 1/4 OZ EXPERIENCED CRACKING/LEAKAGE. THE CUSTOMER STATED, "RX STEVE POTTER FROM LEE AND PERRIN, HENDERSON, NC CALLED IN REGARDING SEVERAL (7 SO FAR) 60ML LUER LOCK SYRINGES THAT ARE CRACKED. I TRIED TO SEARCH BY THE PROVIDED LOT # 8270842 BUT IT WOULD NOT FIND THE ITEM. CAN YOU SEE IF THIS IS VALID FOR YOUR TRACKWISE SYSTEM? HIS CALL BACK # WAS 252/436-1135. THANK YOU."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SEVEN SYRINGES 60ML LL TIP 1ML 2 OZ IN 1/4 OZ EXPERIENCED CRACKING/LEAKAGE. THE CUSTOMER STATED, "RX STEVE POTTER FROM LEE AND PERRIN, HENDERSON, NC CALLED IN REGARDING SEVERAL (7 SO FAR) 60ML LUER LOCK SYRINGES THAT ARE CRACKED. I TRIED TO SEARCH BY THE PROVIDED LOT # 8270842 BUT IT WOULD NOT FIND THE ITEM. CAN YOU SEE IF THIS IS VALID FOR YOUR TRACKWISE SYSTEM? HIS CALL BACK # WAS (B)(6). THANK YOU."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224041 SYRINGE 60ML LL TIP 1ML 2 OZ IN 1/4 OZ PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 8270842 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 Other