BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL PROTECTOR P50J

    MDR report key: 17282821 · Received July 7, 2023

    Report

    Report Number
    2243072-2023-01182
    Event Type
    Malfunction
    Date Received
    July 7, 2023
    Date of Event
    June 14, 2023
    Report Date
    August 29, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905151170
    PMA / PMN Number
    K130197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD PHASEAL PROTECTOR P50J WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE CUSTOMER REPORTED THAT THE PROTECTOR CRACKED AND DAMAGED. WHEN ATTACHING THE PROTECTOR TO THE VIAL, DAMAGE TO THE PROTECTOR WAS OBSERVED . D1: MEDICAL DEVICE BRAND NAME: BD PHASEAL PROTECTOR P50J. D2: MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON, S.A.. D4: UDI #: (B)(4). D4: MEDICAL DEVICE CATALOG #: 515111. G2: MANUFACTURING LOCATION: (B)(4). G.5. PMA / 510(K)#: K130197.

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. D.4 DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN . 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 FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 19-JUN-2023. H6: INVESTIGATION SUMMARY: ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED, OBSERVING THE PROTECTOR WAS CRACKED AROUND THE CONNECTION TO THE VIAL. IT WAS ALSO NOTED THAT NOT ALL OF THE PLASTIC WRAPPING WAS REMOVED FROM AROUND THE VIAL, INCREASING THE DIAMETER OF THE VIAL NECK WHICH CAN CREATE RESISTANCE WHEN ATTACHING THE PROTECTOR. DIMENSIONAL TESTING WAS PERFORMED ON THE VIAL AND THE DIAMETER OF THE VIAL WAS FOUND TO BE 20.50 MM, WHICH IS ABOVE THE RECOMMENDED SIZE FOR THE PROTECTOR USED. PRODUCT UNDERGOES VISUAL AND FUNCTIONAL TESTING THROUGHOUT MANUFACTURING TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING LEAKAGE TESTING AND VERIFICATION ALL CRITICAL DIMENSION ARE WITHIN SPECIFICATION. AS LOT INFORMATION FOR THIS INCIDENT WAS NOT AVAILABLE, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. BASED ON THE SAMPLE INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT IS RELATED TO THE INCORRECT VIAL SIZE FOR THE PROTECTOR THAT WAS USED, MEASURING LARGER THAN SPECIFICATION FOR THE PROTECTOR USED, REQUIRING GREATER FORCE WHEN ATTEMPTING TO CONNECT THE PROTECTOR ON TO THE VIAL WHICH ULTIMATELY CAUSED IT TO BREAK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL PROTECTOR P50J WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE CUSTOMER REPORTED THAT THE PROTECTOR CRACKED AND DAMAGED. WHEN ATTACHING THE PROTECTOR TO THE VIAL, DAMAGE TO THE PROTECTOR WAS OBSERVED .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD PHASEAL¿ PROTECTOR WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE CUSTOMER REPORTED THAT THE PROTECTOR CRACKED AND DAMAGED. WHEN ATTACHING THE PROTECTOR TO THE VIAL, DAMAGE TO THE PROTECTOR WAS OBSERVED . THE REPORTEC PRODUCT WAS P55, BUT IT MAY BE P50J.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL PROTECTOR P50J WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE CUSTOMER REPORTED THAT THE PROTECTOR CRACKED AND DAMAGED. WHEN ATTACHING THE PROTECTOR TO THE VIAL, DAMAGE TO THE PROTECTOR WAS OBSERVED .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498472 BD PHASEAL PROTECTOR P50J INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515117 UNKNOWN 00382905151170

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown