BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK TIP BULK STERILE CONVENIENCE PAK

    MDR report key: 11244546 · Received January 28, 2021

    Report

    Report Number
    9610847-2021-00041
    Event Type
    Malfunction
    Date Received
    January 28, 2021
    Date of Event
    December 30, 2020
    Report Date
    February 17, 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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED FINAL LOT NUMBER 0041890 AND ALL APPLICABLE SUB-ASSEMBLY LOT NUMBERS. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LIQUID LEAKED PAST THE BD SYRINGE LUER-LOK¿ TIP BULK STERILE CONVENIENCE PAK PLUNGER. THIS OCCURRED WITH 293 SEPARATE SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ARE REPORTING TO YOU AN OBSERVED DEFECT TREND WITH BD SYRINGES WHICH CONTINUOUSLY FOUND LIQUID PASS OVER PLUNGER AND THEN API WILL PRECIPITATE TO FORM POWDER AFTER LIQUID EVAPORATED." "ALLOWING LIQUID PAST THE PLUNGER ALLOWING FOR VISIBLE LIQUID OR CRYSTALLIZATION."

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LIQUID LEAKED PAST THE BD SYRINGE LUER-LOK¿ TIP BULK STERILE CONVENIENCE PAK PLUNGER. THIS OCCURRED WITH 293 SEPARATE SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ARE REPORTING TO YOU AN OBSERVED DEFECT TREND WITH BD SYRINGES WHICH CONTINUOUSLY FOUND LIQUID PASS OVER PLUNGER AND THEN API WILL PRECIPITATE TO FORM POWDER AFTER LIQUID EVAPORATED." "ALLOWING LIQUID PAST THE PLUNGER ALLOWING FOR VISIBLE LIQUID OR CRYSTALLIZATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138450 BD SYRINGE LUER-LOK TIP BULK STERILE CONVENIENCE PAK PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 305617 0041890 30382903056171

    Patients

    Seq Age Sex Outcome Treatment
    1