BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFESTEP HUBER NEEDLE SET 20G X 1 IN

    MDR report key: 15221553 · Received August 12, 2022

    Report

    Report Number
    3006260740-2022-03162
    Event Type
    Malfunction
    Date Received
    August 12, 2022
    Date of Event
    December 7, 2021
    Report Date
    October 10, 2022
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    FPA
    UDI-DI
    00801741066221
    PMA / PMN Number
    K153440
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER HAS RECEIVED THE SAMPLE AND IS PENDING EVALUATION. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Additional Manufacturer Narrative · 0

    H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, TREND ANALYSIS, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE (IF AVAILABLE), AND APPLICABLE FMEA DOCUMENTS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A DAMAGED INFUSION SET WAS CONFIRMED AND THE CAUSE IS CURRENTLY UNDER INVESTIGATION. THE PRODUCT RETURNED FOR EVALUATION WAS TWO 20GA X 0.75" SAFESTEP SAFETY INFUSION SETS. THE FIRST PRODUCT SAMPLE WAS EVALUATED AND THE FOLLOWING OBSERVATIONS WERE MADE: A TEAR IN THE EXTENSION TUBE WAS SEEN AT THE INTERFACE OF THE PROXIMAL LUER ADAPTER THE FRACTURE SURFACES OF THE DAMAGE CONTAINED STRIATION-LIKE PATTERNS, MATERIAL BUCKLING AND DISCOLORATION WHICH WERE INDICATIVE OF FLEXURAL FATIGUE BASED FAILURES, WHICH MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE EXTENSION TUBING DAMAGE. REPETITIVE MECHANICAL STRESSES SUCH AS TWISTING AND KINKING MAY HAVE CONTRIBUTED TO THE OBSERVED EVENT; HOWEVER, IT APPEARED THAT ADDITIONAL UNIDENTIFIED FACTORS ALSO CONTRIBUTED. THE DEVICE IS A SUPPLIED COMPONENT AND THE SUPPLIER HAS BEEN NOTIFIED OF THIS EVENT. EXAMINATION OF THE SECOND SAMPLE DID NOT REVEAL ANY DAMAGE OR EVIDENCE OF LEAKAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT'S MEDIAL SAFE STEP TUBING/NEEDLE CRACKED AND LEAKING. BLOOD FLOW BACK UP IN BOTH LUMENS, LATERAL LUMEN OF SAFE STEP NEEDLE ALSO PROBABLE PULLED BY PATIENT AND BLEEDING AT ACCESS SITE. BOTH LUMENS LIKELY OPEN FLOW DURING THIS TIME BEFORE DISCOVERED. PATIENT GRANDMOTHER CALLED OUT UPON REGISTERED NURSE ENTRY & ASSESSMENT OF PATIENT. THIS REGISTERED NURSE NOTED BLOOD FLOW IN BOTH MEDIAL & LATERAL LUMENS OF THE DOUBLE LUMEN PORT. MEDIAL TUBING FOUND TO BE CRACKED UPON FLUSH. BOTH NEEDLES DEACCESSED PER POLICY. BMT TEAM NOTIFIED. ADDITIONAL INFORMATION RECEIVED 08/02/2022: IS THIS A DUAL LUMEN PORT? O YES, IT WAS AS DUAL LUMEN PLACED ON (B)(6) 2021. WERE BOTH LUMENS ACCESSED? O YES, BOTH LUMENS WERE ACCESSED ON (B)(6) 2021 AT 1030AM. DID THIS HAPPEN MORE THAN ONE TIME TO THE PATIENT? O NO, THAT I HAVE DOCUMENTATION OF. ARE THERE ANY ISSUES WITH THE PORT? O NO DOCUMENTED ISSUES. BOTH PORT LUMENS FLUSHED EASILY AND HAD BRISK BLOOD RETURN AT THE TIME OF ACCESS ON (B)(6). NO CONCERNS WERE DOCUMENTED FROM 12/2 TO 12/7 WHEN LEAKING/CRACK WAS NOTED.

    Description of Event or Problem · 0

    IT WAS REPORTED" PATIENT'S MEDIAL SAFE STEP TUBING/NEEDLE CRACKED AND LEAKING. BLOOD FLOW BACK UP IN BOTH LUMENS, LATERAL LUMEN OF SAFE STEP NEEDLE ALSO PROBABLE PULLED BY PATIENT AND BLEEDING AT ACCESS SITE. BOTH LUMENS LIKELY OPEN FLOW DURING THIS TIME BEFORE DISCOVERED. PATIENT GRANDMOTHER CALLED OUT UPON RN ENTRY & ASSESSMENT OF PATIENT. THIS RN NOTED BLOOD FLOW IN BOTH MEDIAL & LATERAL LUMENS OF THE DOUBLE LUMEN PORT. MEDIAL TUBING FOUND TO BE CRACKED UPON FLUSH. BOTH NEEDLES DEACCESSED PER POLICY. BMT TEAM NOTIFIED." "ADDITIONAL INFORMATION RECEIVED 08/02/2022: IS THIS A DUAL LUMEN PORT? YES, IT WAS AS DUAL LUMEN PLACED ON (B)(6) 2021. WERE BOTH LUMENS ACCESSED? YES, BOTH LUMENS WERE ACCESSED ON 12/2/2021 AT 1030AM. DID THIS HAPPEN MORE THAN ONE TIME TO THE PATIENT? NO, THAT I HAVE DOCUMENTATION OF. ARE THERE ANY ISSUES WITH THE PORT? NO DOCUMENTED ISSUES. BOTH PORT LUMENS FLUSHED EASILY AND HAD BRISK BLOOD RETURN AT THE TIME OF ACCESS ON 12/2. NO CONCERNS WERE DOCUMENTED FROM 12/2 TO 12/7 WHEN LEAKING/CRACK WAS NOTED." ADDITIONAL INFORMATION RECEIVED: THE RN NOTED BLOOD FLOW IN BOTH MEDIAL & LATERAL LUMENS OF THE DOUBLE LUMEN PORT. MEDIAL TUBING FOUND TO BE CRACKED UPON FLUSH. BOTH NEEDLES DEACCESSED PER POLICY. ONCOMING RN, AWARE AND NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1818095 SAFESTEP HUBER NEEDLE SET 20G X 1 IN SET, ADMINISTRATION, INTRAVASCULAR FPA C.R. BARD, INC. (BASD) -3006260740 N/A UNKNOWN 00801741066221

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO Female Other