BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 15636554 · Received October 19, 2022

    Report

    Report Number
    9617032-2022-01055
    Event Type
    Malfunction
    Date Received
    October 19, 2022
    Date of Event
    October 11, 2022
    Report Date
    November 10, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    00382903673384
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL: YES. D9: RETURNED TO MANUFACTURER ON: 2022-11-01. H.6. INVESTIGATION SUMMARY:BD RECEIVED 400 SAMPLES (BATCH: 2080380 - 100 SAMPLES, BATCH: 2150913 - 200 SAMPLES AND BATCH: 2164963 - 100 SAMPLES) AND 3 PHOTOGRAPHS FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. AN EVALUATION OF THE PHOTOS AND SAMPLES WAS PERFORMED AND, THE ISSUE OF DEFORMED BLISTER PACKAGING WAS OBSERVED. ADDITIONALLY, 10 RETENTION SAMPLES FROM THE BD INVENTORY OF EACH BATCH NUMBERS: 2080380, 2150913 AND 2164963 WERE VISUALLY INSPECTED, AND NO DEFECTS WERE FOUND. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE FROM THE RETURNED SAMPLES AND PHOTOGRAPHS PROVIDED. BD WAS UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2080380, MEDICAL DEVICE EXPIRATION DATE: 2024-03-31, DEVICE MANUFACTURE DATE: 2022-03-21. MEDICAL DEVICE LOT #: 2150913, MEDICAL DEVICE EXPIRATION DATE: 2024-06-30, DEVICE MANUFACTURE DATE: 2022-05-30. MEDICAL DEVICE LOT #: 2164963, MEDICAL DEVICE EXPIRATION DATE: 2024-06-30. DEVICE MANUFACTURE DATE: 2022-06-13. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE DEVICE EXPERIENCED DAMAGED OR OPEN PACKAGE UNITS WHERE STERILITY WAS IS COMPROMISED. STERILITY IS QUESTIONED. THIS EVENT OCCURRED 61 TIMES WITH LOT 2080380. THIS EVENT OCCURRED 253 TIMES WITH LOT 2150913. THIS EVENT OCCURRED 142 TIMES WITH LOT 2164963. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: COMPLAINT FROM ALICE HO MIU LING NETHERSOLE HOSPITAL. THE CUSTOMER 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 DAMAGED OR OPEN PACKAGE UNITS WHERE STERILITY WAS IS COMPROMISED. STERILITY IS QUESTIONED. THIS EVENT OCCURRED 61 TIMES WITH LOT: 2080380. THIS EVENT OCCURRED 253 TIMES WITH LOT: 2150913. THIS EVENT OCCURRED 142 TIMES WITH LOT: 2164963. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: COMPLAINT FROM (B)(6) HOSPITAL. THE CUSTOMER 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
    2920716 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10. 00382903673384

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown