BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT AFFIRM ATT SYSTEM 100 EA

    MDR report key: 16916037 · Received May 11, 2023

    Report

    Report Number
    1119779-2023-00547
    Event Type
    Injury
    Date Received
    May 11, 2023
    Date of Event
    April 12, 2023
    Report Date
    July 6, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LIO
    UDI-DI
    00382904462550
    PMA / PMN Number
    K920536
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD INTEGRATED DIAGNOSTIC SOLUTIONS INITIATED INVESTIGATION ON THE CUSTOMER REPORT REGARDING GLASS USER INJURY WHILE USING THE AFFIRM ATTS (CATALOG # 446255), BATCH # UNKNOWN. PREVIOUS INVESTIGATION DID NOT REVEAL ANY CHANGES TO MATERIALS THAT COULD DIRECTLY CAUSE THIS INJURY. A REVIEW OF PAST COMPLAINTS DOES NOT INDICATE TREND BY ATTS BATCH. BD IMPLEMENTED THE PACKAGING OF THE ATTS AMPULE CRUSHING TOOL IN ORDER TO PREVENT FUTURE OCCURRENCE OF THIS ISSUE. ALL CURRENT ATTS KITS CONTAIN 1 TOOL WHICH WILL BE PROVIDED IN EACH KIT INDEFINITELY.

    Additional Manufacturer Narrative · 0

    D4. MEDICAL DEVICE LOT #: UNKNOWN. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. H.3. 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 · 0

    THIS REPORT IS FOR PATIENT 1 OF 2. IT WAS REPORTED THAT WHILE USING THE KIT AFFIRM ATT SYSTEM 100 EA THAT TWO LAB TECHS SUSTAINED MINOR CUTS ON THEIR FOREFINGER FROM A SHARD OF GLASS WHEN SQUEEZING THE ATTS PLASTIC VIAL TO BREAK THE GLASS AMPULE INSIDE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES THAT TWO TECHS SUSTAINED MINOR CUTS ON THEIR FOREFINGER FROM A SHARD OF GLASS WHEN SQUEEZING THE ATTS PLASTIC VIAL TO BREAK THE GLASS AMPULE INSIDE. (SMALL PIECE OF GLASS PROTRUDED FROM THE PLASTIC VIAL IN EACH INSTANCE). THE FIRST OCCURRENCE WAS ON 4/12/23 AND THE OTHER OCCURRENCE WAS A FEW DAYS PRIOR (DIFFERENT TECH). THERE WAS NO PATIENT SPECIMEN INVOLVED (OCCURRENCE PRIOR TO SAMPLE COLLECTION). NEITHER TECH REQUIRED MEDICAL TREATMENT OR HAD ANY OTHER ILL EFFECTS AFTER THE INCIDENT. LOT#-NOT AVAILABLE CASE CONTACT CONFIRMED THAT NEITHER TECH USED THE GREEN ATTS DISPENSING TOOL/AMPULE OPENER INCLUDED WITH THE BOX OF 10 ATTS REAGENT VIALS. NEXT STEPS (IF NECESSARY): THE CUSTOMER WILL REVIEW WITH THE TECHS THE IMPORTANCE OF USING THE ATTS DISPENSING TOOL TO PREVENT FUTURE INJURIES FROM OCCURRING. CUSTOMER IS ALSO REQUESTING ADDITIONAL ATTS DISPENSING TOOLS TO HAVE ON HAND FOR USE SINCE THEY HAVE MULTIPLE EXAM ROOMS. RESOLUTION ACHIEVED (Y/N)? : YES. QUANTITY RECEIVED AND QUANTITY AFFECTED: 1 BOX WAS THIS ISSUE INVOLVING PATIENT OR NONPATIENT SAMPLES? NON-PATIENT SAMPLES AFFIRM - 446255 - AMPULES BREAKING THROUGH THE PLASTIC SLEEVE.

    Description of Event or Problem · 0

    THIS REPORT IS FOR PATIENT 1 OF 2. IT WAS REPORTED THAT WHILE USING THE KIT AFFIRM ATT SYSTEM 100 EA THAT TWO LAB TECHS SUSTAINED MINOR CUTS ON THEIR FOREFINGER FROM A SHARD OF GLASS WHEN SQUEEZING THE ATTS PLASTIC VIAL TO BREAK THE GLASS AMPULE INSIDE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES THAT TWO TECHS SUSTAINED MINOR CUTS ON THEIR FOREFINGER FROM A SHARD OF GLASS WHEN SQUEEZING THE ATTS PLASTIC VIAL TO BREAK THE GLASS AMPULE INSIDE. (SMALL PIECE OF GLASS PROTRUDED FROM THE PLASTIC VIAL IN EACH INSTANCE). THE FIRST OCCURRENCE WAS ON (B)(6)2023 AND THE OTHER OCCURRENCE WAS A FEW DAYS PRIOR (DIFFERENT TECH). THERE WAS NO PATIENT SPECIMEN INVOLVED (OCCURRENCE PRIOR TO SAMPLE COLLECTION). NEITHER TECH REQUIRED MEDICAL TREATMENT OR HAD ANY OTHER ILL EFFECTS AFTER THE INCIDENT. LOT#-NOT AVAILABLE. CASE CONTACT CONFIRMED THAT NEITHER TECH USED THE GREEN ATTS DISPENSING TOOL/AMPULE OPENER INCLUDED WITH THE BOX OF 10 ATTS REAGENT VIALS. NEXT STEPS (IF NECESSARY): THE CUSTOMER WILL REVIEW WITH THE TECHS THE IMPORTANCE OF USING THE ATTS DISPENSING TOOL TO PREVENT FUTURE INJURIES FROM OCCURRING. CUSTOMER IS ALSO REQUESTING ADDITIONAL ATTS DISPENSING TOOLS TO HAVE ON HAND FOR USE SINCE THEY HAVE MULTIPLE EXAM ROOMS. RESOLUTION ACHIEVED (Y/N)? : YES QUANTITY RECEIVED AND QUANTITY AFFECTED: 1 BOX WAS THIS ISSUE INVOLVING PATIENT OR NONPATIENT SAMPLES? NON-PATIENT SAMPLES AFFIRM - 446255 - AMPULES BREAKING THROUGH THE PLASTIC SLEEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602753 KIT AFFIRM ATT SYSTEM 100 EA DEVICE, SPECIMEN COLLECTION LIO BECTON, DICKINSON & CO. (SPARKS) UNKNOWN 00382904462550

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other