BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 9112438 · Received September 24, 2019

    Report

    Report Number
    1024879-2019-01693
    Event Type
    Malfunction
    Date Received
    September 24, 2019
    Date of Event
    August 24, 2019
    Report Date
    January 2, 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: 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 25 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 #: PAS-19-1429-FA, ASSOCIATED WITH RES82351. H3 OTHER TEXT : SEE SECTION H.10.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR SLEEVE LEAKAGE WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, EVALUATION OF THE CUSTOMER SAMPLES WAS PERFORMED AND THE SAMPLES WERE OBSERVED TO BE WITHIN SPECIFICATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE OCCURRED DURING USE WITH A BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "BLOOD SPILLAGE FROM ECLIPSE SAFETY NEEDLE DURING BLOOD COLLECTION" 11000 OCCURRENCES WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE OCCURRED DURING USE WITH A BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "BLOOD SPILLAGE FROM ECLIPSE SAFETY NEEDLE DURING BLOOD COLLECTION". 11,000 OCCURRENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 · 1

    IT WAS REPORTED THAT LEAKAGE OCCURRED DURING USE WITH A BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "BLOOD SPILLAGE FROM ECLIPSE SAFETY NEEDLE DURING BLOOD COLLECTION." 11000 OCCURRENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907897 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