BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL ADMINISTRATION PRODUCTS - IV BAG ACCESS

    MDR report key: 12278183 · Received August 4, 2021

    Report

    Report Number
    2243072-2021-02024
    Event Type
    Malfunction
    Date Received
    August 4, 2021
    Date of Event
    July 7, 2021
    Report Date
    September 13, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    LHI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THE CUSTOMER RAISED A COMPLAINT ABOUT A CYTO-AD Z® INLINE/4 SET BECAUSE SALINE SOLUTION LEAKED FROM THE CONNECTION BETWEEN THE MAIN LINE SPIKE AND THE TUBING DURING ADMINISTRATION OF CHEMOTHERAPY. THERE WAS NO CONTAMINATION WITH HAZARDOUS MEDICATION, AS ONLY SALINE SOLUTION COULD ESCAPE FROM THIS LEAK. THE ORIGINAL OFFENDING SAMPLE WAS NOT PROVIDED. NO SAMPLE WAS AVAILABLE BUT TWO PHOTOS WERE PROVIDED. BOTH PICTURES SHOWED THE DEFECTIVE CYTO-AD Z® INLINE / 4 SET SEALED IN A PLASTIC BAG. THE SPIKE HAD NO PROTECTIVE CAP, THE CLAMP WAS CLOSED AND THE INLINE SPIKE CONNECTOR WAS OPEN. THE FOUR CHEMOTHERAPY ACCESSES (Y-SITE PORTS) WERE EACH CLOSED WITH THEIR ORIGINAL CLOSURE PLUGS. THE PHOTOS GAVE THE IMPRESSION THAT NO CHEMOTHERAPY WAS CONNECTED YET WHEN THE USER NOTICED THE LEAK. NUMEROUS WATERY FLUID DROPS WERE VISIBLE ON THE INSIDE OF THE PLASTIC BAG WALL. THE DROPS WERE EVENLY DISTRIBUTED AROUND THE DEVICE. AN EXACT SOURCE OF THE LEAKAGE WAS NOT NOTICEABLE, INSTEAD, ON ONE OF THE PHOTOS, A MANUALLY CIRCLED AREA AROUND THE CONNECTION IN QUESTION, WAS TO INDICATE THE LEAK. HOWEVER, THE PHOTO OF THE LEAKING AREA WAS NOT SHARP FOCUSING AND DETAILED ENOUGH FOR AN ANALYSIS OF THE LEAKAGE CAUSE. AFTER ALL, SPIKE AND TUBING APPEARED TO BE PERFECTLY GLUED. MAIN CAUSE: WITHOUT THE OPPORTUNITY TO INVESTIGATE THE ORIGINAL SAMPLE, THE MOST PROBABLE CAUSE OF THE LEAKAGE CANNOT BE DETERMINED DEFINITELY. BASICALLY, THE CONNECTION IN QUESTION COULD HAVE BEEN LEAKY DUE TO MANUFACTURING OR HANDLING ERRORS BY THE USER. SUMMARY AND EVALUATION: COMPLAINT IS NOT CONFIRMED, AS IT WAS NOT POSSIBLE TO DETERMINE THE EXACT CAUSE OF THE LEAK. IN ADDITION TO A VERY ISOLATED PROCESSING OR MATERIAL ERROR, A HANDLING ERROR BY THE USER MUST ALSOBE CONSIDERED TO MAYBE BEING THE CAUSE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ ADMINISTRATION PRODUCTS - IV BAG ACCESS EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING ADMINISTRATION OF CHEMO TO PATIENT, SALINE LEAKED FROM THE MAIN SPIKE CONNECTION. THERE IS NO EXPOSURE TO CHEMO AS THE CONNECTION THAT WAS LEAKING IS CONNECTED TO THE SALINE BOTTLE. CHEMO IS USUALLY CONNECTED TO THE 4 PORTS BELOW THE MAIN SPIKE.

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURE: 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. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 BD PHASEAL¿ ADMINISTRATION PRODUCTS - IV BAG ACCESS EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING ADMINISTRATION OF CHEMO TO PATIENT, SALINE LEAKED FROM THE MAIN SPIKE CONNECTION. THERE IS NO EXPOSURE TO CHEMO AS THE CONNECTION THAT WAS LEAKING IS CONNECTED TO THE SALINE BOTTLE. CHEMO IS USUALLY CONNECTED TO THE 4 PORTS BELOW THE MAIN SPIKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173072 BD PHASEAL ADMINISTRATION PRODUCTS - IV BAG ACCESS PHASEAL ADMINISTRATION SET LHI BECTON DICKINSON A62783-1

    Patients

    Seq Age Sex Outcome Treatment
    1