BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXT/1CQ/MQ/STD/50CM

    MDR report key: 10080100 · Received May 21, 2020

    Report

    Report Number
    2243072-2020-00799
    Event Type
    Malfunction
    Date Received
    May 21, 2020
    Date of Event
    May 4, 2020
    Report Date
    June 11, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 2020-05-29. H.6. INVESTIGATION SUMMARY : WHEN CHECKING THE ACTUAL PRODUCT WE RECEIVED, THE TUBE WAS FOUND TO BE DAMAGED. SINCE THE DAMAGED PART WAS SWOLLEN AND THE WALL THICKNESS WAS THIN, IT WAS PRESUMED TO HAVE RUPTURED. IN ADDITION, ALL PRODUCTS OF THIS PRODUCT HAVE BEEN VISUALLY INSPECTED IMMEDIATELY BEFORE THEY ARE PUT INTO INDIVIDUAL PACKAGES, AND ALL PAST PRODUCTION LOTS HAVE UNDERGONE A SHIPPING TEST (THE RELEVANT JIS AIRTIGHTNESS STANDARD: 150 KPA, NO WATER LEAKAGE UNDER PRESSURE FOR 15 MINUTES). IN ADDITION, THE JIS TENSILE STRENGTH STANDARD: NO ABNORMALITY WAS OBSERVED WHEN A FORCE OF 15 N OR MORE WAS APPLIED FOR 15 SECONDS OR MORE.* NO ABNORMALITY WAS OBSERVED IN THE SAMPLING INSPECTION). IT IS PROBABLE THAT THIS EVENT WAS CAUSED BY RUPTURE DUE TO EXCESSIVE PRESSURE APPLIED TO THE INSIDE OF THE TUBE RATHER THAN THE CONDITION OF THE DAMAGED PART. 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 EXT/1CQ/MQ/STD/50CM LINE EXPLODED. THIS WAS DISCOVERED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN USING PRODUCT FOR INJECTING CT CONTRAST MEDIUM AT EMERGENCY VISIT, THE LINE WAS EXPLODED. THE SALES REP VISITED THE HOSPITAL ON MAY 6. AND EXPLAINED HOW TO USE IN RIGHT WAY.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EXT/1CQ/MQ/STD/50CM LINE EXPLODED. THIS WAS DISCOVERED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN USING PRODUCT FOR INJECTING CT CONTRAST MEDIUM AT EMERGENCY VISIT, THE LINE WAS EXPLODED. THE SALES REP VISITED THE HOSPITAL ON MAY 6 AND EXPLAINED HOW TO USE IN RIGHT WAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541673 EXT/1CQ/MQ/STD/50CM TUBING FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other