BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STPCK Q-SYTE WHT 360DEG W/O NUT CAP NS

    MDR report key: 10814545 · Received November 9, 2020

    Report

    Report Number
    9610847-2020-00349
    Event Type
    Malfunction
    Date Received
    November 9, 2020
    Date of Event
    October 15, 2020
    Report Date
    January 19, 2021
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    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

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 0051267 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS INCIDENT, PICTURE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURES, DEFECTS WERE OBSERVED WITH THE PRODUCT MOLDING AND BLACK SPOTS WERE IDENTIFIED. THROUGH THE PICTURE SAMPLES ONLY, IT IS NOT POSSIBLE TO IDENTIFY WHETHER THE BLACK SPOTS ARE LOOSE OR EMBEDDED. IF THE SPOTS ARE EMBEDDED, IT WOULD BE A RESULT OF THE AUTOMATED MOLDING PROCESS. IF THE SPOTS ARE LOOSE, THIS ISSUE MAY BE RELATED TO THE MACHINERY USED WITHIN THE PRODUCTION PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEFORMATIONS WERE FOUND ON 217 STPCKS Q-SYTE WHT 360DEG W/O NUT CAP NS IN LOT 0051267, AND 217 STOPCOCKS IN LOT 0036908 BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: DURING QUALITY INSPECTION, MOLDING DEFECTS (BURRS AND DEFECTIVE MOLDING) WERE FOUND IN A TOTAL OF (B)(4) PRODUCTS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0051267. MEDICAL DEVICE EXPIRATION DATE: NA. DEVICE MANUFACTURE DATE: 2020-02-20. MEDICAL DEVICE LOT #: 0036908. MEDICAL DEVICE EXPIRATION DATE: NA. DEVICE MANUFACTURE DATE: 2020-02-05. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEFORMATIONS WERE FOUND ON 217 STPCKS Q-SYTE WHT 360DEG W/O NUT CAP NS IN LOT 0051267, AND 217 STOPCOCKS IN LOT 0036908 BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: DURING QUALITY INSPECTION, MOLDING DEFECTS (BURRS AND DEFECTIVE MOLDING) WERE FOUND IN A TOTAL OF 434 PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272120 STPCK Q-SYTE WHT 360DEG W/O NUT CAP NS STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1