BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL INJECTOR N35-O

    MDR report key: 11023712 · Received December 16, 2020

    Report

    Report Number
    3003152976-2020-00570
    Event Type
    Malfunction
    Date Received
    December 16, 2020
    Date of Event
    November 17, 2020
    Report Date
    March 2, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D1: MEDICAL DEVICE BRAND NAME: BD PHASEAL INJECTOR N35-O. D4: MODEL # 515052. D4: MEDICAL DEVICE LOT #: 2002106. D4: MEDICAL DEVICE EXPIRATION DATE: 2021-01-31. D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2020-12-15. H4: DEVICE MANUFACTURE DATE: 2020-02-13. H6: INVESTIGATION SUMMARY: ONE PHOTO AND SEVERAL PHYSICAL SAMPLES WERE PROVIDED TO OUR QUALITY ENGINEER FOR EVALUATION. UPON INSPECTING THE PRODUCT USING MAGNIFICATION, WHITE PARTICLES CAN BE OBSERVED ON THE SURFACE OF ONE HUNDRED AND SEVENTY-NINE OF THE SAMPLE INJECTORS RETURNED. ADDITIONAL EVALUATIONS DETERMINED NO WHITE PARTICLES WERE FOUND WITHIN THE FLUID PATH. TEN RETAINED SAMPLES OF LOT 2002106 WERE ALSO EVALUATED, NO PARTICLES WERE IDENTIFIED ON ANY OF THESE SAMPLES. ADDITIONALLY, LEAKAGE TESTING WAS PERFORMED ON THIRTY OF THE RETURNED SAMPLES. EACH INJECTOR WAS CONNECTED TO A CONNECTOR, PENETRATING THE DEVICE TEN TIMES. IN ALL CASES THE PRODUCT FUNCTIONED PROPERLY AND NO LEAKAGE WAS OBSERVED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2002106, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THE REPORTED ISSUE WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. PRODUCT UNDERGOES VISUAL INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS, RESULTS FOR THE REPORTED LOT WERE REVIEWED AND NO INCIDENTS RELATED TO FOREIGN MATTER OR LEAKAGE WERE IDENTIFIED. STERILIZATION TESTING WAS PERFORMED AND RESULTS WERE FOUND TO BE WITHIN SPECIFICATION. MANUFACTURING FOR THIS PRODUCT IS PERFORMED IN A CLEAN ROOM WHICH IS KEPT UNDER A POSITIVE PRESSURE TO REDUCE THE CHANCE OF FOREIGN MATTER. CHARACTERIZATION TESTING WAS PERFORMED AND IDENTIFIED THE PARTICLES CONSISTED OF TYVEK PAPER WHICH IS USED IN THE PACKAGING FOR THIS PRODUCT. MANUFACTURING EQUIPMENT UNDERGOES ROUTINE MAINTENANCE AND CLEARLY DEFINED CLEANING PROCEDURES, ALL RECORDS VERIFY THE EQUIPMENT WAS PROPERLY CLEANED ACCORDING TO OUR PROCEDURES. BASED ON THE QUALITY TEAM'S INVESTIGATION, A PROJECT HAS BEEN INITIATED TO FURTHER INVESTIGATE AND ADDRESS THE WHITE PARTICLES THAT WERE OBSERVED. GIVEN THAT WE COULD NOT REPLICATE THE LEAKAGE FAILURE THAT WAS REPORTED, A ROOT CAUSE COULD NOT BE ESTABLISHED AT THIS TIME. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNKNOWN PHASEAL OPTIMA PROTECTOR 20 HAD FOREIGN MATTER AND LEAKED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT P 20-O LEAKED UPON DISENGAGEMENT FROM THE INJECTOR AND THERE IS WHITE POWDER IN THE STERILE PACKAGING. PER ATTACHED PIR - 1. P 20-O LEAKED UPON DISENGAGEMENT FROM INJECTOR 2. WHITE POWDER IN STERILE PACKAGING. PER ADDITIONAL INFORMATION RECEIVED- PHARMACY TECHNICIAN REPORTED "POWDER CONTAMINATION" OF N35-O PHASEAL OPTIMA WHEN REMOVING FROM SEALED PACKAGE. THE AFFECTED LOT WAS #2002106. SEE ATTACHED PICTURES. TECHNICIAN MENTIONED THIS WAS THE SAME LOT NUMBER THAT FAILED THE PREVIOUS DAY THAT RESULTED IN CHEMOTHERAPY OUTSIDE OF THE MEMBRANES DURING PREPARATION."

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNKNOWN PHASEAL OPTIMA PROTECTOR 20 HAD FOREIGN MATTER AND LEAKED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT P 20-O LEAKED UPON DISENGAGEMENT FROM THE INJECTOR AND THERE IS WHITE POWDER IN THE STERILE PACKAGING. PER PIR - P 20-O LEAKED UPON DISENGAGEMENT FROM INJECTOR. WHITE POWDER IN STERILE PACKAGING. PER ADDITIONAL INFORMATION RECEIVED- PHARMACY TECHNICIAN REPORTED "POWDER CONTAMINATION" OF N35-O PHASEAL OPTIMA WHEN REMOVING FROM SEALED PACKAGE. THE AFFECTED LOT WAS #2002106. TECHNICIAN MENTIONED THIS WAS THE SAME LOT NUMBER THAT FAILED THE PREVIOUS DAY THAT RESULTED IN CHEMOTHERAPY OUTSIDE OF THE MEMBRANES DURING PREPARATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1485542 BD PHASEAL INJECTOR N35-O INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON, S.A. 2002106

    Patients

    Seq Age Sex Outcome Treatment
    1