BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET

    MDR report key: 15502581 · Received September 29, 2022

    Report

    Report Number
    2243072-2022-01683
    Event Type
    Injury
    Date Received
    September 29, 2022
    Date of Event
    August 17, 2022
    Report Date
    October 3, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THIS COMPLAINT IS UNABLE TO BE CONFIRMED. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED. SINCE THERE WERE NO SAMPLES RETURNED, NO PICTURES, AND THE BATCH WAS UNKNOWN, OUR MANUFACTURING AND PROCESS INSPECTION RECORDS OF 165 LOTS OF THE PRODUCT CONCERNED (#367286) MANUFACTURED FROM JULY 2020 TO THE END OF JUNE 2021 WERE REVIEWED (THE PERIOD OF TIME WAS SELECTED BECAUSE IT WAS REPORTED TO HAVE HAPPENED ABOUT 12 MONTHS BEFORE). NO ABNORMALITIES THAT COULD CAUSE MALFUNCTION OF THE SAFETY SHIELDS WERE FOUND. FURTHERMORE, THE RELEASE INSPECTION RECORDS OF THE 165 LOTS WERE REVIEWED. NO RECORDS OF ABNORMALITIES IN THE APPEARANCE, THE BREAKAWAY FORCE, SUSTAINING FORCE AND SECURITY FORCE OF THE SAFETY SHIELDS WERE FOUND. AS IT WAS REPORTED THAT THE CUSTOMER DIDN¿T ACTIVATE THE SAFETY SHIELD PROPERLY, IT WAS CONSIDERED THAT THERE WAS NOTHING WRONG WITH THE PRODUCT. MOREOVER, NO ABNORMALITIES THAT COULD LEAD TO MALFUNCTION OF THE SAFETY SHIELD WERE FOUND FROM REVIEWING THE MANUFACTURING AND INSPECTION RECORDS AS DESCRIBED ABOVE. AS STATED IN THE IFU, PLEASE HOLD THE END OF SAFETY SHIELD AND TUBING, AND SLIDE THE SAFETY SHIELD STRAIGHT TO COVER THE WINGED NEEDLE WITHOUT HOLDING WINGS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET IT WAS DIFFICULT TO ACTIVATE THE SAFETY FEATURE RESULTING IN A NEEDLE STICK INJURY - POST USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE USER COLLECTED BLOOD AND DIDN'T ACTIVATE SHARPS SAFETY CORRECTLY. THE USER THEN RECEIVED A NEEDLE STICK FROM USED BUTTERFLY. TESTING FOR BOTH PATIENT AND MO AS PER STANDARD NSW HEALTH POLICY. NEEDLE STICK OCCURRED WHEN TRYING TO ACTIVATE SAFETY. FLAW IN TECHNIQUE RATHER THAN DEVICE. ADDITIONAL INFORMATION RECEIVED: AS IN THE SHORT DESCRIPTION. BASIC USER ERROR ON THE PART OF THE MO, HENCE THE REASON A PIR WAS NOT SUBMITTED SOONER. INCIDENT OCCURRED SOME TIME LAST YEAR. VAGUE DETAILS SILVER LININGS- LEARNING OPPORTUNITY FOR BOTH THIS CNC AND THE MO IN QUESTION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET IT WAS DIFFICULT TO ACTIVATE THE SAFETY FEATURE RESULTING IN A NEEDLE STICK INJURY - POST USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE USER COLLECTED BLOOD AND DIDN'T ACTIVATE SHARPS SAFETY CORRECTLY. THE USER THEN RECEIVED A NEEDLE STICK FROM USED BUTTERFLY. TESTING FOR BOTH PATIENT AND MO AS PER STANDARD NSW HEALTH POLICY. NEEDLE STICK OCCURRED WHEN TRYING TO ACTIVATE SAFETY. FLAW IN TECHNIQUE RATHER THAN DEVICE. ADDITIONAL INFORMATION RECEIVED: AS IN THE SHORT DESCRIPTION. BASIC USER ERROR ON THE PART OF THE MO, HENCE THE REASON A PIR WAS NOT SUBMITTED SOONER. INCIDENT OCCURRED SOME TIME LAST YEAR. VAGUE DETAILS SILVER LININGS- LEARNING OPPORTUNITY FOR BOTH THIS CNC AND THE MO IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2930011 BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention