BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 18078966 · Received November 6, 2023

    Report

    Report Number
    9617032-2023-01593
    Event Type
    Malfunction
    Date Received
    November 6, 2023
    Date of Event
    October 17, 2023
    Report Date
    December 1, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903688611
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD RECEIVED 86 SAMPLES (LOT 3163216) FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. (B)(4) RETURNED SAMPLES WERE DRAW-TESTED WITH DEIONIZED WATER. FROM THIS TESTING, IT WAS DETERMINED THAT ALL 20 TUBES DREW WITHIN SPECIFICATION. 1 PHOTOGRAPH WAS ATTACHED SHOWING UNDERFILL. BD WAS ABLE TO CONFIRM CUSTOMERS¿ INDICATED FAILURE MODE BASED ON THE ATTACHED PHOTOGRAPH. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. ALTHOUGH THE PHOTOGRAPH PROVIDED BY THE CUSTOMER DOES INDICATE A LACK OF DRAW, THERE IS NO EVIDENCE THAT THE DEVICE WAS THE CAUSE OF THIS DEFECT. TESTING OF RETURNED SAMPLES FROM THIS LOT NUMBER DID NOT CONFIRM THE REPORTED DEFECT. 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. 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 THE IDENTIFICATION OF EMERGING TRENDS. THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL/CORRECTED INFORMATION: D.1. DEVICE AVAILABLE FOR EVAL:YES. D.1. RETURNED TO MANUFACTURER ON: 07-NOV-2023.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES ON AN INFANT, THE TUBE DID NOT FILL. THIS EVENT OCCURRED 3 TIMES AND THERE IS NO REPORT OF ADVERSE OR INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLOODDRAW WITH SMALL INFANT. DURING BLOOD COLLECTION THE EDTA TUBE DID NOT FILL, ONLY A FEW DROPS CAME IN THE TUBE. (SEE PIC). EVENTUALLY THEY TRIED ANOTHER TUBE/LOTNUMBER, THEN THE TUBE DID FILL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES ON AN INFANT, THE TUBE DID NOT FILL. THIS EVENT OCCURRED 3 TIMES AND THERE IS NO REPORT OF ADVERSE OR INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLOODDRAW WITH SMALL INFANT. DURING BLOOD COLLECTION THE EDTA TUBE DID NOT FILL, ONLY A FEW DROPS CAME IN THE TUBE. (SEE PIC). EVENTUALLY THEY TRIED ANOTHER TUBE/LOTNUMBER, THEN THE TUBE DID FILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341252 BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 3187221 50382903688611

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown