BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTOR P20-O

    MDR report key: 9279996 · Received November 5, 2019

    Report

    Report Number
    3003152976-2019-00757
    Event Type
    Malfunction
    Date Received
    November 5, 2019
    Date of Event
    September 25, 2019
    Report Date
    December 31, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905150647
    PMA / PMN Number
    K181221
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1902153, MEDICAL DEVICE EXPIRATION DATE: 1/31/2020, DEVICE MANUFACTURE DATE: 3/14/2019. INVESTIGATION SUMMARY: ONE PHOTO AND FIVE UNUSED SAMPLES FROM PROTECTOR LOT 1903161 WERE RETURNED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE PHOTO, A TRANSLUCENT DROP WAS OBSERVED ON THE SURFACE OF THE PROTECTOR MEMBRANE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOTS 1903161 AND 1902153, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. DURING MANUFACTURING, LEAKAGE TESTING IS PERFORMED, PENETRATING THE INJECTOR AND MAKING COMPONENTS TEN TIMES TO VERIFY IF ANY LEAKS OCCUR. TESTING WAS REVIEWED FOR PROTECTOR LOTS 1903161 AND 1902153, ALL RESULTS WERE FOUND TO BE WITHIN SPECIFICATION. FUNCTIONAL TESTING WAS PERFORMED ON ALL SAMPLES RECEIVED, PENETRATING THE PROTECTOR ALONG WITH SAMPLE INJECTORS TEN TIMES, ALL RESULTS WERE FOUND TO BE ACCEPTABLE WITH NO LEAKS IDENTIFIED. THE TESTING WAS REPEATED USING THIRTY RETAINED SAMPLES FROM LOT 1902153, RESULTS WERE AGAIN FOUND TO BE ACCEPTABLE AND NO LEAKAGES OCCURRED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PROTECTOR P20-O LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 515064 BATCH NO.: 1903161. IT WAS REPORTED ALL THREE P20-0 MEMBRANES OF THE CYCLOPHOSPHAMIDE VIALS HAD RESIDUE AFTER WITHDRAWING FLUID WITH THE N35-0 INJECTOR. PER OPTIMA4 FORM: ALL THREE P20-0 MEMBRANES OF THE CYCLOPHOSPHAMIDE VIALS HAD RESIDUE AFTER WITHDRAWING FLUID WITH THE N35-0 INJECTOR. THE INFUSION ADAPTER C100-0 HAD RESIDUE AFTER TRANSFERRING THE CYCLOPHOSPHAMIDE INTO THE INFUSION BAG WITH THE SAME N35-0 INJECTOR.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PROTECTOR P20-O LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 515064, BATCH NO.: 1903161. IT WAS REPORTED ALL THREE P20-0 MEMBRANES OF THE CYCLOPHOSPHAMIDE VIALS HAD RESIDUE AFTER WITHDRAWING FLUID WITH THE N35-0 INJECTOR. PR 1 OF 6: PER OPTIMA4 FORM: ALL THREE P20-0 MEMBRANES OF THE CYCLOPHOSPHAMIDE VIALS HAD RESIDUE AFTER WITHDRAWING FLUID WITH THE N35-0 INJECTOR. THE INFUSION ADAPTER C100-0 HAD RESIDUE AFTER TRANSFERRING THE CYCLOPHOSPHAMIDE INTO THE INFUSION BAG WITH THE SAME N35-0 INJECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1071025 PROTECTOR P20-O INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 1902153 00382905150647

    Patients

    Seq Age Sex Outcome Treatment
    1 Other