BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK TIP BULK STERILE CONVENIENCE PAK

    MDR report key: 11680876 · Received April 16, 2021

    Report

    Report Number
    9610847-2021-00155
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    March 19, 2021
    Report Date
    March 24, 2021
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903056171
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0150036, MEDICAL DEVICE EXPIRATION DATE: 2025-04-30, DEVICE MANUFACTURE DATE: 2020-06-08. MEDICAL DEVICE LOT #: 0210109, MEDICAL DEVICE EXPIRATION DATE: 2025-07-31, DEVICE MANUFACTURE DATE: 2020-08-20. MEDICAL DEVICE LOT #: 0239033, MEDICAL DEVICE EXPIRATION DATE: 2025-08-31, DEVICE MANUFACTURE DATE: 2020-09-22. MEDICAL DEVICE LOT #: 0272400, MEDICAL DEVICE EXPIRATION DATE: 2025-09-30, DEVICE MANUFACTURE DATE: 2020-10-30. INVESTIGATION SUMMARY: IT WAS REPORTED THAT THERE IS LIQUID FLOWING FROM THE PLUNGER WHEN THE SYRINGES HAVE BEEN FROZEN. TO AID IN THE INVESTIGATION, SEVEN PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. ALL THE PHOTOS SHOW 20ML SYRINGES WITH A DRUG INSIDE. THE DRUG IS BETWEEN THE RUBBER STOPPER RIBS AND A FEW OF THEM SHOW THE DRUG PAST THE RUBBER STOPPER. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305617, LOT NUMBER 0150036. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305617, LOT NUMBER 0210109. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305617, LOT NUMBER 0239033. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305617, LOT NUMBER 0272400. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. HOWEVER, THIS IS DUE TO OFF LABEL USE. THESE SYRINGES ARE NOT SPECIFIED FOR STORAGE AND FROZEN ENVIRONMENTS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 1 BD SYRINGE LUER-LOK" TIP BULK STERILE CONVENIENCE PAK FROM LOT 0150036, 1 FROM LOT 0210109, 2 SYRINGES FROM LOT 0239033, AND 3 FROM LOT 0272400 LEAKED PAST THE PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER STATES DEFECTS IN BD SYRINGES OVER THE PAST FEW WEEKS. THE PROBLEM IS THAT THERE IS LIQUID FLOWING FROM THE PLUNGER (WHEN THE SYRINGES HAVE BEEN FROZEN WE SEE THAT BETWEEN THE 2 LAYERS OF THE PLUNGER THE LIQUID HAS FLOWED, SOMETIMES THE LIQUID HAS EVEN FLOWED COMPLETELY ON THE OTHER SIDE. PISTON)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578901 BD SYRINGE LUER-LOK TIP BULK STERILE CONVENIENCE PAK PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 305617 SEE SECTION H.10. 30382903056171

    Patients

    Seq Age Sex Outcome Treatment
    1