BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50CC LL TIP CONVENIENCE PAK

    MDR report key: 11963788 · Received June 9, 2021

    Report

    Report Number
    9610847-2021-00264
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Date of Event
    May 12, 2021
    Report Date
    June 1, 2021
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    00382903096800
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: IT WAS REPORTED THAT SEVERAL CASES FROM THIS LOT HAVE HAD LEAKING ISSUES. TO AID IN THE INVESTIGATION SIX TRAYS WITH TWENTY UNITS EACH AND FIVE PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. ONE TRAY IS OPENED AND THE OTHER FIVE ARE SEALED. TEN RANDOM SAMPLES WERE SELECTED FOR THE LEAKAGE TEST AND ALL SAMPLES PASSED. THE PHOTOS PROVIDED SHOW THE SAMPLES RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309680, LOT NUMBER 0121938. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM OF LEAKAGE PAST STOPPER REPORTED BY THE CUSTOMER COULDN'T BE CONFIRMED. 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. ROOT CAUSE DESCRIPTION: PROBABLE ROOT CAUSE IS UNKNOWN. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 50CC LL TIP CONVENIENCE PAK LEAKED AND THE PLUNGER WAS BROKEN. THIS OCCURRED ON 20 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SEVERAL CASES FROM THIS LOT HAVE HAD LEAKING ISSUES AND PLUNGERS ARE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860300 SYRINGE 50CC LL TIP CONVENIENCE PAK PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 0121938 00382903096800

    Patients

    Seq Age Sex Outcome Treatment
    1