BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ INFUSION CLAMP M25

    MDR report key: 9539635 · Received January 2, 2020

    Report

    Report Number
    2243072-2019-02935
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    December 18, 2019
    Report Date
    May 12, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    KMK
    UDI-DI
    00382905150852
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW, THIS COMPLAINT WAS DETERMINED TO NOT BE REPORTABLE. IF THE INFUSION CLAMP COMES OFF OR IS DISPLACED, THIS MAY LEAD TO CUSTOMER DISSATISFACTION AS A NEW CLAMP IS REQUIRED BUT DOES NOT LEAD TO ANY DEGREE OF HARM/SERIOUS INJURY. PLEASE CONSIDER MDR VOID.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THE FINAL PRODUCT FOR LOT 1910001 IS MANUFACTURED AT A SUPPLIER SITE. WE HAVE NOTIFIED THE SUPPLIER OF THE REPORTED ISSUE AND PROVIDED SAMPLES FOR EVALUATION. FUNCTIONAL TESTING WAS PERFORMED ON THE SAMPLES PROVIDED, VERIFYING THERE WERE ABLE TO BE PROPERLY CLOSED. A REVIEW OF LOT 1910001 WAS PERFORMED, ALL SAMPLES WERE 100% INSPECTED FOR PRODUCT FUNCTION AND NO DEVIATIONS WERE IDENTIFIED DURING THE MANUFACTURING OF THIS LOT THAT COULD CONTRIBUTE TO THE REPORTED FAILURE. TWENTY RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION, ALL PRODUCT FUNCTIONED AS INTENDED AND WE WERE ABLE TO PROPERLY CLOSE THE CLAMPS WITHOUT ISSUE. BASED ON THE AVAILABLE INFORMATION WE WERE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INFUSION CLAMPS WERE NOT FUNCTIONING WITH A BD PHASEAL¿ INFUSION CLAMP M25. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE INFUSION CLAMPS WOULD NOT CLICK INTO PLACE OR CLOSE PROPERLY AND THAT THE TAB WOULD NOT LOCK INTO PLACE. ADDITIONALLY, THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: I WANTED TO REPORT AN ISSUE THAT TOOK PLACE TODAY WITH SEVERAL INFUSION CLAMPS WHILE AT EMORY. OUT OF 3 BOXES OF 25, SEVERAL OF THEM WOULD NOT "CLICK" INTO PLACE OR CLOSE AS THEY SHOULD, THE SMALL TAB THAT LOCKS THE 2 SIDES TOGETHER WOULDN'T LOCK. OUT OF 3 BOXES, I WOULD GUESS UP TO ~ 30% OF THE SAMPLES HAD THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INFUSION CLAMPS WERE NOT FUNCTIONING WITH A BD PHASEAL¿ INFUSION CLAMP M25. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THAT THE INFUSION CLAMPS WOULD NOT CLICK INTO PLACE OR CLOSE PROPERLY AND THAT THE TAB WOULD NOT LOCK INTO PLACE. ADDITIONALLY, THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: I WANTED TO REPORT AN ISSUE THAT TOOK PLACE TODAY WITH SEVERAL INFUSION CLAMPS WHILE AT EMORY. OUT OF 3 BOXES OF 25, SEVERAL OF THEM WOULD NOT "CLICK" INTO PLACE OR CLOSE AS THEY SHOULD, THE SMALL TAB THAT LOCKS THE 2 SIDES TOGETHER WOULDN'T LOCK. OUT OF 3 BOXES, I WOULD GUESS UP TO ~ 30% OF THE SAMPLES HAD THIS ISSUE.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND 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. THE LOT # REPORTED (191001) IS NOT A MANUFACTURED LOT FOR THIS DEVICE. THE FOLLOWING INFORMATION IS BELIEVED TO BE CORRECT, HOWEVER, WAS NOT ABLE TO BE CONFIRMED: MEDICAL DEVICE LOT #: 1910001. MEDICAL DEVICE EXPIRATION DATE: 2024-09-30. DEVICE MANUFACTURE DATE: 2019-11-07. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INFUSION CLAMPS WERE NOT FUNCTIONING WITH A BD PHASEAL¿ INFUSION CLAMP M25. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE INFUSION CLAMPS WOULD NOT CLICK INTO PLACE OR CLOSE PROPERLY AND THAT THE TAB WOULD NOT LOCK INTO PLACE. ADDITIONALLY, THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: I WANTED TO REPORT AN ISSUE THAT TOOK PLACE TODAY WITH SEVERAL INFUSION CLAMPS WHILE AT EMORY. OUT OF 3 BOXES OF 25, SEVERAL OF THEM WOULD NOT "CLICK" INTO PLACE OR CLOSE AS THEY SHOULD, THE SMALL TAB THAT LOCKS THE 2 SIDES TOGETHER WOULDN'T LOCK. OUT OF 3 BOXES, I WOULD GUESS UP TO ~ 30% OF THE SAMPLES HAD THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4796 BD PHASEAL¿ INFUSION CLAMP M25 INTRAVASCULAR CATHETER SECUREMENT DEVICE KMK BECTON DICKINSON 515085 SEE H.10 00382905150852

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other