BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 9233437 · Received October 24, 2019

    Report

    Report Number
    1024879-2019-01853
    Event Type
    Injury
    Date Received
    October 24, 2019
    Date of Event
    October 6, 2019
    Report Date
    December 13, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903673648
    PMA / PMN Number
    K153309
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. 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. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH CAPA 891355 AND POTENTIAL CAUSES HAVE BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS HAVE BEEN ESTABLISHED AND ARE IN THE PROCESS OF BEING IMPLEMENTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET HAD A RETRACTION FAILURE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367364 , BATCH NO. UNKNOWN (PROVIDED 9021874, 9003599). IT WAS REPORTED THAT THE NEEDLE ONLY RETRACTED HALFWAY RESULTING IN A NEEDLE STICK. PER EMAIL: FAILED SAFETY MECHANISM UPDATE: THE SAFETY DEVICE FOR THE 23 GAUGE BUTTERFLY FAILED. WHEN ACTIVATED THE NEEDLE ONLY RETRACTED INTO THE SAFETY SHEATH HALF WAY. THIS CAUSED THE PHLEBOTOMIST TO GET A NEEDLE STICK AND A BLOOD EXPOSURE. THE PHLEBOTOMIST DID NOT NOTICE THAT THE NEEDLE DID NOT FULLY RETRACT INTO THE SHEATH. AFTER THE COLLECTION THE PHLEBOTOMIST PICKED UP HER USED EQUIPMENT FOR DISPOSAL AND THAT IS WHEN SHE RECEIVED THE NEEDLE STICK INJURY. MY JOB TITLE IS TEAM LEAD FOR PRE/POST ANALYTICS. I AM IN THE SUPERVISOR FOR ALL OF PHLEBOTOMISTS AT THE HOSPITAL. THERE WAS A BLOOD EXPOSURE THAT WAS THE DIRECT RESULT OF THE SAFETY DEVICES FAILURE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MEDICAL DEVICE TYPE: FPA. ADDITIONAL COMMON DEVICE NAME: INTRAVASCULAR ADMINISTRATION SET. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET HAD A RETRACTION FAILURE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367364 BATCH NO. UNKNOWN (PROVIDED 9021874,9003599). IT WAS REPORTED THAT THE NEEDLE ONLY RETRACTED HALFWAY RESULTING IN A NEEDLE STICK. PER EMAIL: FAILED SAFETY MECHANISM. UPDATE: THE SAFETY DEVICE FOR THE 23 GAUGE BUTTERFLY FAILED. WHEN ACTIVATED THE NEEDLE ONLY RETRACTED INTO THE SAFETY SHEATH HALF WAY. THIS CAUSED THE PHLEBOTOMIST TO GET A NEEDLE STICK AND A BLOOD EXPOSURE. THE PHLEBOTOMIST DID NOT NOTICE THAT THE NEEDLE DID NOT FULLY RETRACT INTO THE SHEATH. AFTER THE COLLECTION THE PHLEBOTOMIST PICKED UP HER USED EQUIPMENT FOR DISPOSAL AND THAT IS WHEN SHE RECEIVED THE NEEDLE STICK INJURY. MY JOB TITLE IS TEAM LEAD FOR PRE/POST ANALYTICS. I AM IN THE SUPERVISOR FOR ALL OF PHLEBOTOMISTS AT THE HOSPITAL. THERE WAS A BLOOD EXPOSURE THAT WAS THE DIRECT RESULT OF THE SAFETY DEVICES FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027899 BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) UNKNOWN 50382903673648

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention