BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 9280065 · Received November 5, 2019

    Report

    Report Number
    1024879-2019-01913
    Event Type
    Malfunction
    Date Received
    November 5, 2019
    Date of Event
    October 21, 2019
    Report Date
    January 14, 2020
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686082
    PMA / PMN Number
    K982541
    Removal / Correction Number
    PAS-19-1429-FA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: UPDATE #1: SAMPLES WERE RECEIVED FROM THE CUSTOMER FACILITY FOR CATALOG 368608, LOT 8241870 AND CATALOG 368608, LOT 9010765. NOTE THAT THE COMPLAINT HAD ONLY CAPTURED LOT 9010765 PREVIOUSLY; THEREFORE, THE NEW LOT 8241870 WILL BE INCLUDED IN THE SCOPE OF THE INVESTIGATION BUT HAS NOT BEEN CONFIRMED TO BE ASSOCIATED WITH CAPA 744088 OR PAS-19-1429-FA AT THIS TIME. FURTHER EVALUATION IS BEING CONDUCTED AT THIS TIME. D.4. MEDICAL DEVICE LOT #: 8241870 D.4. MEDICAL DEVICE EXPIRATION DATE: 8/31/2023 H.4. DEVICE MANUFACTURE DATE: 8/29/2018 UPDATE #2: 1. RECALL SUMMARY BD IS CONDUCTING A VOLUNTARY MEDICAL DEVICE RECALL FOR THREE LOTS OF BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLES 22GX1.25 BASED ON CONFIRMED COMPLAINTS THAT THE BEVEL IS MISSING FROM THE NON-PATIENT (NP) NEEDLE END OF THE ECLIPSE BLOOD COLLECTION NEEDLE. 2. PRODUCT AND SCOPE THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE IS A STERILE, SINGLE USE MEDICAL DEVICE. IT CONSISTS OF DOUBLE-ENDED HOLLOW CANNULA, POINTED AT BOTH ENDS AND FIXED INSIDE A PLASTIC SCREW THREAD HUB. THE INTRAVENOUS END OF THE CANNULA IS POINTED FOR INSERTION INTO (USUALLY) THE MEDIAN CUBITAL VEIN OF THE ARM, WHILE THE OTHER END HAS A POINT SUITABLE FOR PIERCING, WITHOUT CORING, THE RUBBER STOPPER OF A BD VACUTAINER® BLOOD COLLECTION TUBE. THIS IS THE NON-PATIENT (NP) END. 3. DESCRIPTION OF ISSUE BD PAS RECEIVED COMPLAINTS FROM CUSTOMERS INDICATING THE ABSENCE OF THE BEVEL ON THE NON-PATIENT (NP) NEEDLE END OF THE ECLIPSE BLOOD COLLECTION NEEDLE PRODUCT, SPECIFICALLY FOR CATALOG # 368608, LOT NUMBERS 8207894, 8354527 & 9025826 CAUSING BLOOD LEAKAGE. SUBSEQUENTLY, ADDITIONAL COMPLAINTS FROM CUSTOMERS INDICATING THE ABSENCE OF THE BEVEL ON THE NON-PATIENT (NP) NEEDLE END OF THE ECLIPSE BLOOD COLLECTION NEEDLE WERE RECEIVED ON LOT # 9010765. THE INVESTIGATION INDICATES THAT THIS LOT IS IMPACTED AND THE RECALL HAS BEEN EXPANDED TO INCLUDE IT. 4. SUMMARY TABLE OF THE # OF COMPLAINTS AND MDRS IN SCOPE THERE WERE A TOTAL OF (B)(4) COMPLAINTS AND 25 MDRS WITHIN SCOPE AT THE TIME THE EXPANDED FIELD ACTION DECISION WAS MADE. 5. HHE SUMMARY THE RISK OF TRANSMISSION OF BLOODBORNE PATHOGENS, UNNECESSARY POST-EXPOSURE PROPHYLAXIS DUE TO EXPOSURE OF HCW TO CONTAMINATED BLOOD AND POTENTIAL FOR A NEEDLESTICK INJURY FROM A BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION WITH A MISSING NP NEEDLE BEVEL IS CONSIDERED TO BE VERY LOW. ADDITIONALLY, AN OVERALL RISK ASSESSMENT WAS TAKEN INTO CONSIDERATION. OF ALL COMPLAINTS BD RECEIVED, THERE WERE NO INDICATION OF THE END USER BEING SUBJECTED TO DIRECT BLOOD EXPOSURE OR NEEDLESTICK INJURY. TAKING ALL THESE FACTORS INTO CONSIDERATION, THE HEALTH HAZARD ASSOCIATED WITH THIS PRODUCT FAILURE IS REMOTE. 6. INVESTIGATION SUMMARY BD PAS HAS INITIATED CAPA 744088 TO FURTHER INVESTIGATE THIS ISSUE AND IMPLEMENT CORRECTIVE ACTIONS. 7. RECALL REFERENCE #, EITHER BD INTERNAL OR RES/Z# PLEASE REFERENCE BD RECALL #: (B)(4) , ASSOCIATED WITH(B)(4) . H3 OTHER TEXT : SEE SECTION H.10.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE CURRENT CUSTOMER COMPLAINT ISSUE IS ONLY ON LOT 9010765; THE CUSTOMER HAD TAKEN THE NON-PATIENT END (NP) CAPS OFF THE NEEDLE FOR LOT 8241870 AND PLACED THEM ON THE NP END NEEDLE OF LOT 9010765. THE NP CAPS ALSO CONTAIN THE LABEL FOR THE LOT NUMBER INFORMATION, SO THIS MAY BE THE REASON FOR CONFUSION WHEN IDENTIFYING THE LOT OF PRODUCT. THE CUSTOMER HAS CONFIRMED WITH US THAT THERE IS NO ISSUE WITH LOT 8241870. AS A RESULT INFORMATION FOR LOT 8241870 HAS BEEN TAKEN OUT OF THIS COMPLAINT LEAVING ONLY THE INFORMATION FOR LOT 9010765.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HAS BEEN FOUND EXPERIENCING 9600 OCCURRENCES OF INABILITY TO CONTAIN BLOOD BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: NEEDLE IS NOT THERE IN NON PATIENT END.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HAS BEEN FOUND EXPERIENCING 9600 OCCURRENCES OF INABILITY TO CONTAIN BLOOD BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: NEEDLE IS NOT THERE IN NON PATIENT END.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 · 1

    IT HAS BEEN REPORTED THAT THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HAS BEEN FOUND EXPERIENCING 9600 OCCURRENCES OF INABILITY TO CONTAIN BLOOD BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: NEEDLE IS NOT THERE IN NON PATIENT END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070932 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 9010765 50382903686082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other