BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE

    MDR report key: 13170634 · Received January 5, 2022

    Report

    Report Number
    8041187-2021-01092
    Event Type
    Malfunction
    Date Received
    January 5, 2022
    Date of Event
    December 13, 2021
    Report Date
    December 16, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ACCORDING TO THE DHR REVIEW RESULTS, THERE WAS NO QN RAISED FOR LEAKAGE IN THE ASSEMBLY NEEDLE BATCH USED TO PRODUCE THIS COMPLAINT BATCH. NO PHOTO WAS RECEIVED FOR THIS COMPLAINT. ACTUAL USED SAMPLE WAS RECEIVED FOR THIS COMPLAINT. THE SAMPLE WAS OBSERVED WITH RUBBER SLEEVE SIDE PIERCE. THERE ARE NO VISIBLE DEFECTS SEEN ON THE NP CANNULA OF THE RETURNED ACTUAL SAMPLE AFTER REMOVING THE RUBBER SLEEVE. THERE WAS 1 PUNCTURED MARK SEEN THE RUBBER SLEEVE OF THE ACTUAL SAMPLE. THE FOLLOWING SIMULATION WAS CARRIED OUT. THE NP SHIELD OF A FBN SAMPLE WAS DELIBERATELY UN-SHIELD IN A NON-STRAIGHT MANNER (REFER TO FIGURE 7 OF ATTACHMENT A). A ¿BENT¿ RUBBER SLEEVE IS OBSERVED AFTER UN-SHIELDING (REFER TO FIGURE 8 OF ATTACHMENT A). THE SIMULATED SAMPLE IS THEN ASSEMBLED TO THE HOLDER, THEN MOUNTED TO THE SLEEVE FUNCTION TESTER TO CONDUCT A SLEEVE FUNCTION TEST WITH 1 VACUTAINER TUBE. REFER TO FIGURE 9 & 10 OF ATTACHMENT A. AFTER THE VACUTAINER IS REMOVED, RUBBER SLEEVE SIDE PIERCE IS OBSERVED, AND LEAKAGE IS ALSO OBSERVED ON THE SIDE PIERCED AREA OF THE RUBBER SLEEVE. REFER TO FIGURE 11 OF ATTACHMENT A THE RUBBER SLEEVE SIDE PIERCE COULD HAVE HAPPENED OUTSIDE TUAS MANUFACTURING PROCESS. THE COMPLAINT TREND WILL BE TRACKED AND MONITORED. RISK REVIEW PER RISK MANAGEMENT WKSHEET DOCUMENT, VRMW35-001 REVISION 05 (LINE 3.8.3.3), THE SEVERITY IS S4 OCCURRENCE = ((TOTAL COMPLAINT RECEIVED IN DEC-21 / AVERAGE SALES VOLUME (B)JUN-21 TO NOV-21) X 100%)* P2 = ((1 / 7320250) X 100%)*0.0005 = 0.00000 WHICH IS O1. JUN-21, JUL-21, AUG-21, SEP-21, OCT-21, NOV-21, AVERAGE: 6448583, 6656917, 7040250, 7598583, 7948583, 8228583, 7320250. THE RISK IS IN THE INVESTIGATE REGION PER VO8-518 REV 23. THOUGH THE RISK IS IN THE INVESTIGATION REGION, MITIGATION HAS BEEN MADE AS PER DOCUMENTED IN VRMW35-001 TO REDUCE THE RISK.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE HAS BEEN FOUND EXPERIENCING POOR SLEEVE FUNCTION AND LEAKAGE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: DURING THE FIRST COLLECTION, BLOOD LEAKS FROM THE LOWER END OF THE STRAIGHT NEEDLE AND CONTAMINATES THE NEEDLE HOLDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110781 BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE BLOOD COLLECTION NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 1113064

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown