BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV SET/J/60DROP/1CQ/SB/50CM/PB

    MDR report key: 8124573 · Received December 3, 2018

    Report

    Report Number
    2243072-2018-01693
    Event Type
    Malfunction
    Date Received
    December 3, 2018
    Date of Event
    November 8, 2018
    Report Date
    December 20, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLIER RECEIVED THE ACTUAL ITEM, THE TUBE WAS BURNING OUT AS SUGGESTED. IN ADDITION, THIS PRODUCT HAS UNDERGONE THE ALL-IN-ONE INSPECTION JUST BEFORE PUTTING IT IN INDIVIDUAL PACKAGING, AND SHIPPING TESTS IN ALL PAST PRODUCTION LOTS. (JIS TENSILE STRENGTH STANDARD: JIS 15,000 N OR MORE IS APPLIED WHEN APPLIED FOR 15 SECONDS OR LONGER). THERE WAS NO ABNORMALITY WAS RECOGNIZED IN THE SAMPLING INSPECTION. SUPPLIER CONDUCTED A TENSILE (RUPTURE) STRENGTH CHECK TEST ON THE PART OF OUR PRESERVED SPECIMEN (PRODUCT STORED FOR EACH PRODUCTION NUMBER * N = 5) EARLIER THIS YEAR AND THE LATEST LOT, NO VARIATION OR STRENGTH REDUCTION WAS OBSERVED. SINCE THE CROSS SECTION IS DISTORTED, IT WAS ESTIMATED THAT THE TUBE WAS BROKEN DUE TO EXCESSIVE LOAD APPLIED TO THE TUBE ADHESION PART DURING USE. NO DHR REVIEW COULD BE CARRIED OUT AS THE LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE IV SET/J/60DROP/1CQ/SB/50CM/PB. THERE WAS AN ISSUE WITH LEAKAGE.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). 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 DURING USE OF THE IV SET/J/60DROP/1CQ/SB/50CM/PB THERE WAS AN ISSUE WITH LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964036 IV SET/J/60DROP/1CQ/SB/50CM/PB IV SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other