BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PROTECTOR P

    MDR report key: 8804674 · Received July 18, 2019

    Report

    Report Number
    3003152976-2019-00474
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Date of Event
    July 1, 2019
    Report Date
    October 2, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    30382905151171
    PMA / PMN Number
    K130197
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THERE WERE MULTIPLE LOT NUMBERS THAT THE DEVICE COULD BELONG TO. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1902122. MEDICAL DEVICE EXPIRATION DATE: 1/31/2024. DEVICE MANUFACTURE DATE: 2/22/2019. MEDICAL DEVICE LOT #: 1901122. MEDICAL DEVICE EXPIRATION DATE: 12/31/2023. DEVICE MANUFACTURE DATE: 02/06/2019. MEDICAL DEVICE LOT #: 1901110. MEDICAL DEVICE EXPIRATION DATE: 12/31/2023. DEVICE MANUFACTURE DATE: 01/21/2019. INVESTIGATION SUMMARY: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. WHILE PHASEAL NEEDLES ARE DESIGNED TO REDUCE CORING, THERE ARE SEVERAL FACTORS THAT MAY IMPACT CORING TENDENCY. CORING FROM THE MEMBRANE MAY OCCUR DUE TO FRAGMENTATION CAUSED BY MULTIPLE INJECTIONS OR EXCESSIVE WELDING OF THE MEMBRANE. CORING OF THE RUBBER STOPPER MAY RESULT DEPENDING ON THE STOPPER QUALITY, THE DESIGN AND DIMENSIONS OF THE NEEDLES USED, OR IF A POOR CONNECTION OF THE PROTECTOR OCCURS. A DEVICE HISTORY REVIEW WAS PERFORMED FOR SUSPECTED LOTS 1902122, 1901122, 1901110, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. FRAGMENTATION TESTING IS PERFORMED ACCORDING TO PROCEDURE, TO EVALUATE ANY PARTICULATES GENERATED BY THE INJECTOR WHEN MATED TO OTHER COMPONENTS AFTER TEN ACTIVATIONS. FRAGMENTATION TESTING WAS REVIEWED FOR THE SUSPECTED LOT S AND RESULTS WERE FOUND TO BE ACCEPTABLE. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE AT THIS TIME. THE M12 ASSEMBLY FIXTURE IS RECOMMENDED TO EASE THE CONNECTION OF THE PROTECTOR TO THE VIAL. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED FOR FUTURE OCCURRENCE. PRIOR TO THE INVESTIGATION OF THIS COMPLAINT A CAPA 688697 WAS OPENED TO ASSES CORING DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CORING OCCURRED WITH A BD PROTECTOR P55. THIS OCCURRED ON 15 SEPARATE OCCASIONS DURING USE, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: CORING OCCURRED.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CORING OCCURRED WITH A BD PROTECTOR P55. THIS OCCURRED ON 15 SEPARATE OCCASIONS DURING USE, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: CORING OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594943 BD PROTECTOR P INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. UNKNOWN 30382905151171

    Patients

    Seq Age Sex Outcome Treatment
    1 Other