BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD IV-SET P 150 CM PVC L-L

    MDR report key: 9991974 · Received April 23, 2020

    Report

    Report Number
    2243072-2020-00648
    Event Type
    Malfunction
    Date Received
    April 23, 2020
    Date of Event
    April 3, 2020
    Report Date
    June 29, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1011832. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. UNFORTUNATELY, A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING. WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TUBING CLAMP IS UNABLE TO BE TURNED FOR ADJUSTMENTS DURING USE WITH A BD IV-SET P 150 CM PVC L-L. THIS OCCURRED ON 10 SEPARATE OCCASIONS, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FROM A MEDICAL FACILITY THAT WE SUPPLIED WITH YOUR INFUSION SET, CLAIMED THAT THE DIALS CANNOT BE TURNED FOR ADJUSTMENT DURING USING WITH SEVERAL PACKAGES.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE LOT #: 1011832 WAS REPORTED, HOWEVER, THIS IS NOT A LOT # MANUFACTURED BY BD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. INITIAL REPORTER PHONE #: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUBING CLAMP IS UNABLE TO BE TURNED FOR ADJUSTMENTS DURING USE WITH A BD IV-SET P 150 CM PVC L-L. THIS OCCURRED ON 10 SEPARATE OCCASIONS, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FROM A MEDICAL FACILITY THAT WE SUPPLIED WITH YOUR INFUSION SET, CLAIMED THAT THE DIALS CANNOT BE TURNED FOR ADJUSTMENT DURING USING WITH SEVERAL PACKAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455586 BD IV-SET P 150 CM PVC L-L INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other