BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 8493896 · Received April 8, 2019

    Report

    Report Number
    1024879-2019-00709
    Event Type
    Malfunction
    Date Received
    April 8, 2019
    Date of Event
    March 18, 2019
    Report Date
    April 23, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686082
    PMA / PMN Number
    K982541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. 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. INVESTIGATION CONCLUSION: AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. ROOT CAUSE DESCRIPTION: AS THERE WAS NO SAMPLE OR PHOTO AVAILABLE FOR EVALUATION, A ROOT CAUSE COULD NOT BE DETERMINED. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLES HAD SAFETIES BREAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "MATERIAL NO. 368608, BATCH NO. 9010767. IT WAS REPORTED THAT THE SAFETY IS BREAKING ON 10 NEEDLES IN HER BOX.. CUSTOMER IS REPORTING THE SAFETY BREAKING ON 10 NEEDLES IN HER BOX.. ADDITIONAL INFO AWARE COMMENTS; WHAT IS THE DATE OF OCCURRENCE? (B)(6) 2019. DID ALL 10 HAPPEN ON THE SAME DAY? IF NOT BECAUSE SPECIFIC THE NUMBER OF OCCURRENCES FOR EACH DATE. 1 HAPPENED THIS DAY. THROUGHOUT USING THESE NEEDLES, WE HAVE HAD OTHERS THAT I FORWARDED TO MEDLINE. WHEN DID THE SAFETY BREAK? (BEFORE USE, DURING USE, AFTER USE) IT BROKE WHEN CLOSING THE SAFETY (SAME THING WITH THE PREVIOUS OCCURRENCES). COULD YOU EXPLAIN INTO FURTHER DETAIL, HOW THE SAFETY IS BREAKING? IT BREAKS WHEN THE SAFETY IS GETTING CLOSED. DO YOU HAVE ANY PATIENT IDENTIFIERS FOR THESE 10 OCCURRENCES? HAS HAPPENED WHEN STUDENTS ARE JUST PRACTICING CLOSING SAFETY'S AND AFTER A BLOOD DRAW. DO YOU HAVE ANY UNUSED PRODUCT (5-10 SAMPLES) THAT CAN BE SENT IN FOR INVESTIGATION? YES, WE DO. CAN YOU PLEASE SEND DETAILS FOR MAILING BACK TO YOU? IS THERE A WAY WE CAN GET A REPLACEMENT FOR THE AFFECTED LOT? WERE THERE ANY NEEDLE STICKS? IF SO, WHAT WAS THE MEDICAL INTERVENTION? NO."

    Additional Manufacturer Narrative · 1

    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 A BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLES HAD SAFETIES BREAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "MATERIAL NO. 368608 BATCH NO. 9010767''. IT WAS REPORTED THAT THE SAFETY IS BREAKING ON 10 NEEDLES IN HER BOX.. CUSTOMER IS REPORTING THE SAFETY BREAKING ON 10 NEEDLESS IN HER BOX.. ADDITIONAL INFO AWARE COMMENTS, WHAT IS THE DATE OF OCCURRENCE? (B)(6) 2019. DID ALL 10 HAPPEN ON THE SAME DAY? IF NOT BECAUSE SPECIFIC THE NUMBER OF OCCURRENCES FOR EACH DATE. 1 HAPPENED THIS DAY. THROUGHOUT USING THESE NEEDLES, WE HAVE HAD OTHERS THAT I FORWARDED TO MEDLINE. WHEN DID THE SAFETY BREAK? (BEFORE USE, DURING USE, AFTER USE) IT BROKE WHEN CLOSING THE SAFETY (SAME THING WITH THE PREVIOUS OCCURRENCES). COULD YOU EXPLAIN INTO FURTHER DETAIL, HOW THE SAFETY IS BREAKING? IT BREAKS WHEN THE SAFETY IS GETTING CLOSED. DO YOU HAVE ANY PATIENT IDENTIFIERS FOR THESE 10 OCCURRENCES? HAS HAPPENED WHEN STUDENTS ARE JUST PRACTICING CLOSING SAFETY AND AFTER A BLOOD DRAW. DO YOU HAVE ANY UNUSED PRODUCT (5-10 SAMPLES) THAT CAN BE SENT IN FOR INVESTIGATION? YES, WE DO. CAN YOU PLEASE SEND DETAILS FOR MAILING BACK TO YOU? IS THERE A WAY WE CAN GET A REPLACEMENT FOR THE AFFECTED LOT? WERE THERE ANY NEEDLE STICKS? IF SO, WHAT WAS THE MEDICAL INTERVENTION? NO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283434 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 9010767 50382903686082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other