BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER

    MDR report key: 13595507 · Received February 24, 2022

    Report

    Report Number
    1024879-2022-00099
    Event Type
    Malfunction
    Date Received
    February 24, 2022
    Date of Event
    February 15, 2022
    Report Date
    March 11, 2022
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FOZ
    PMA / PMN Number
    K030573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1201462. MEDICAL DEVICE EXPIRATION DATE: 2023-07-31 . DEVICE MANUFACTURE DATE: 2021-07-20. MEDICAL DEVICE LOT #: 1201461. MEDICAL DEVICE EXPIRATION DATE:2023-07-31 . DEVICE MANUFACTURE DATE: 2021-07-20. 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: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2022-02-22. H6: INVESTIGATION SUMMARY: BD RECEIVED 2 CUSTOMER SAMPLES, 1 FROM EACH COMPLAINT LOT, FOR EVALUATION. THE CUSTOMER SAMPLES WERE SUBJECTED TO FUNCTIONAL TESTING TO PERFORM A VISUAL FOR SPLATTER. ALL SAMPLES PASSED THE TEST WITH NO DEFECTS OBSERVED AND THE CUSTOMER'S INDICATED FAILURE MODE OF SPLATTER WAS NOT OBSERVED. 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. BD WAS UNABLE TO CONFIRM THE CUSTOMER REPORTED FAILURE MODE BASED ON CUSTOMER SAMPLE TESTING RESULTS. BASED ON A REVIEW OF BATCH RECORDS AND THE SAMPLE RESULTS, BD COULD NOT DETERMINE A ROOT CAUSE FOR THE ISSUE OF SPLATTER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD UT-PBBCS 23G 12 PAH CE, THE DEVICE EXPERIENCED BLOOD SPLATTER/LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT BLOOD SPLATTERS OUT FROM THE TOP OF THE BODY OF THE DEVICE. ON (B)(6)2022 I RECEIVED A CALL FROM CX, SHE SAID SHE WAS CALLING BECAUSE SHE HAD ALREADY RESPONDED TO MY EMAILS, HOWEVER I DID NOT GET ANYTHING AS OF (B)(6)2022. SHE PROVIDED HER ADDRESS AND LOT NUMBERS OF THE PRODUCTS. MATERIAL # 368689 LOT # 1055588. MATERIAL #368688 LOT # 1201462. MATERIAL # 368688 LOT # 1201461. SHE WILL BE SENDING SAMPLES IN FOR INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD UT-PBBCS 23G 12 PAH CE, THE DEVICE EXPERIENCED BLOOD SPLATTER/LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT BLOOD SPLATTERS OUT FROM THE TOP OF THE BODY OF THE DEVICE. ON (B)(6) 2022 I RECEIVED A CALL FROM CX, SHE SAID SHE WAS CALLING BECAUSE SHE HAD ALREADY RESPONDED TO MY EMAILS, HOWEVER I DID NOT GET ANYTHING AS OF (B)(6) 2022. SHE PROVIDED HER ADDRESS AND LOT NUMBERS OF THE PRODUCTS. MATERIAL # 368689 LOT # 1055588; MATERIAL #368688 LOT # 1201462; MATERIAL # 368688 LOT # 1201461. SHE WILL BE SENDING SAMPLES IN FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2443701 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER INTRAVASCULAR CATHETER FOZ BECTON, DICKINSON & CO., (BD) SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown