BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 15615915 · Received October 17, 2022

    Report

    Report Number
    1024879-2022-00609
    Event Type
    Malfunction
    Date Received
    October 17, 2022
    Date of Event
    October 6, 2022
    Report Date
    November 16, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903673365
    PMA / PMN Number
    K030573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPES ARE AS FOLLOWS. MEDICAL DEVICE TYPE: JKA / FPA. COMMON DEVICE NAME: BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2059667, MEDICAL DEVICE EXPIRATION DATE: 2024-02-29, DEVICE MANUFACTURE DATE: 2022-02-28; MEDICAL DEVICE LOT #: 2136675, MEDICAL DEVICE EXPIRATION DATE: 2024-05-31, DEVICE MANUFACTURE DATE: 2022-05-16; MEDICAL DEVICE LOT #:2150907, MEDICAL DEVICE EXPIRATION DATE: 2024-05-31, DEVICE MANUFACTURE DATE: 2022-05-30. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL: YES. D9: RETURNED TO MANUFACTURER ON: 2022-10-31. H.6. INVESTIGATION SUMMARY: BD RECEIVED 44 SAMPLES FROM LOT 2136675), 8 SAMPLES FROM LOT 2059667) AND 8 SAMPLES FROM LOT 2150907 AND 4 PHOTOS FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. AN EVALUATION OF THE RETURNED SAMPLES AND PHOTOS WAS PERFORMED, AND THE ISSUE OF DEFORMED PACKAGING WAS OBSERVED. ADDITIONALLY, 50 RETAINED SAMPLES FROM EACH LOT NUMBER OF THE BD INVENTORY PROVIDED WERE VISUALLY INSPECTED, AND NO DEFORMED PACKAGING WAS FOUND. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BECAUSE THE DEFECT WAS EVIDENT IN THE PHOTOS AND SAMPLES PROVIDED. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE ORIGINAL MANUFACTURING LOCATION WAS INCORRECTLY FILED. PLEASE SEE THE CHANGES BELOW. D.3. MANUFACTURING LOCATION: BECTON, DICKINSON AND COMPANY (BD). G.1. MANUFACTURING LOCATION: BECTON, DICKINSON AND COMPANY (BD).

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE DEVICE EXPERIENCED A DAMAGED OR OPEN UNIT PACKAGE WHERE STERILITY IS COMPROMISED. THIS EVENT OCCURRED 8 TIMES WITH LOT 2059667. THIS EVENT OCCURRED 4 TIMES WITH LOT 2136675. THIS EVENT OCCURRED 6 TIMES WITH LOT 2150907. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: WE COMPLAINED THAT THE CAPSULE PACKAGES WERE FOUND DEFORMED. THERE IS UNCERTAINTY ABOUT SAFETY IN TERMS OF STERILIZATION AND ITS APPLICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE DEVICE EXPERIENCED A DAMAGED OR OPEN UNIT PACKAGE WHERE STERILITY IS COMPROMISED. THIS EVENT OCCURRED 8 TIMES WITH LOT: 2059667. THIS EVENT OCCURRED 4 TIMES WITH LOT: 2136675. THIS EVENT OCCURRED 6 TIMES WITH LOT: 2150907. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: WE COMPLAINED THAT THE CAPSULE PACKAGES WERE FOUND DEFORMED. THERE IS UNCERTAINTY ABOUT SAFETY IN TERMS OF STERILIZATION AND ITS APPLICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE DEVICE EXPERIENCED A DAMAGED OR OPEN UNIT PACKAGE WHERE STERILITY IS COMPROMISED. THIS EVENT OCCURRED 8 TIMES WITH LOT: 2059667. THIS EVENT OCCURRED 4 TIMES WITH LOT: 2136675. THIS EVENT OCCURRED 6 TIMES WITH LOT: 2150907. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: WE COMPLAINED THAT THE CAPSULE PACKAGES WERE FOUND DEFORMED. THERE IS UNCERTAINTY ABOUT SAFETY IN TERMS OF STERILIZATION AND ITS APPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2386865 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 367336 SEE H.10. 50382903673365

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown