BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J CONNECTOR LOOP

    MDR report key: 10388926 · Received August 10, 2020

    Report

    Report Number
    9610847-2020-00235
    Event Type
    Malfunction
    Date Received
    August 10, 2020
    Date of Event
    July 21, 2020
    Report Date
    August 28, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    30382903851219
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: AS NO PHYSICAL SAMPLE, PICTURE SAMPLE, OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THERE ARE CURRENT QUALITY CONTROLS IN PLACE TO DETECT THIS TYPE OF PRODUCT MALFUNCTION DURING THE PRODUCTION PROCESS. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT J CONNECTOR LOOP SPLIT OPEN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAD A J-LOOP CONNECTOR SPLIT OPEN WHILE DELIVERING CONTRAST IN CT. THE RATE OF DELIVERY WAS 5ML PER SECOND.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT J CONNECTOR LOOP SPLIT OPEN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAD A J-LOOP CONNECTOR SPLIT OPEN WHILE DELIVERING CONTRAST IN CT. THE RATE OF DELIVERY WAS 5 ML PER SECOND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853373 J CONNECTOR LOOP J LOOP FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 385121 UNKNOWN 30382903851219

    Patients

    Seq Age Sex Outcome Treatment
    1 Other