BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IV START KIT

    MDR report key: 5083990 · Received September 17, 2015

    Report

    Report Number
    1030451-2015-00002
    Event Type
    Injury
    Date Received
    September 17, 2015
    Date of Event
    August 20, 2015
    Report Date
    September 12, 2015
    Manufacturer
    MEDICAL ACTION INDUSTRIES
    Product Code
    LRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE COMPLAINT RECEIVED (B)(6) 2015, MAI OPENED INTERNAL (B)(4), TO FURTHER INVESTIGATE AND INITIATE APPROPRIATE CORRECTIVE/PREVENTIVE ACTIONS. MAI ISSUED A SUPPLIER CORRECTIVE ACTION REPORT, (B)(4), TO THE MANUFACTURER/SUPPLIER, (B)(4), ON (B)(6) 2015 TO FURTHER ADDRESS THIS COMPONENT ISSUE. (B)(4) HAS INDICATED COMMUNICATION WITH THE END USER TO DIRECTLY OBTAIN THE APPLICATOR FOR INVESTIGATION PURPOSES. MAI WAS ONLY ABLE TO INVESTIGATE PICTURES, CURRENT INVENTORY SUPPLY, AND TRENDING RECORDS FOR INTERNAL INVESTIGATION. MAI TRENDING ANALYSIS FOUND NO OTHER COMPLAINTS RECEIVED THIS YEAR THAT WERE SIMILAR IN NATURE AND CURRENT INVENTORY SAMPLING WAS ACCEPTABLE. THE APPLICATOR WAS NOT BROKEN UPON RECEIPT BY THE END USER, THIS GLASS BREAKAGE OCCURRED DURING THE INITIATION OF THE APPLICATOR. (B)(4) NOTIFIED MAI THAT THEY HAVE OFFERED RE-EDUCATION ON APPLICATOR USE TO THE HEALTHCARE FACILITY. (B)(4) HAS ALSO INITIATED AN INTERNAL INVESTIGATION INTO THE OCCURRENCE TO DETERMINE THE ROOT CAUSE AND CORRECTIVE/PREVENTIVE ACTIONS NECESSARY TO APPROPRIATELY RESPOND. AT THIS TIME THEY INFORMED MAI THAT THEY ARE STILL PERFORMING INVESTIGATION INTO THE COMPLAINT AND DO NOT HAVE A CONCLUSION AVAILABLE AT THIS TIME. (B)(4) HAS THIS COMPONENT REGISTERED AS A DRUG UNDER AN NDA AND THEREFORE WILL BE SUBMITTING THEIR INCIDENT REPORT TO THE FDA SRP PORTAL FOR THIS INJURY.

    Description of Event or Problem · 1

    MEDICAL ACTION INDUSTRIES (MAI) IS THE MANUFACTURER OF AN IV START KIT (ITM: 68917, IV START 100/CS) THAT CONTAINS A CHLORAPREP SEPP ONE-STEP APPLICATOR 0.67ML (ITM: 260441NSB, (B)(4)) MANUFACTURED BY (B)(4). ON (B)(6) 2015, MAI RECEIVED A CUSTOMER COMPLAINT FROM FROEDTERT & THE MEDICAL COLLEGE OF WISCONSIN INDICATING A NURSE WAS INJURED BY A CHLORAPREP SEPP ONE-STEP APPLICATOR 0.67ML CONTAINED WITHIN A MAI MANUFACTURED IV START KIT. THE COMPLAINT STATES, "THIS MORNING ONE OF OUR NURSES WAS INJURED AS A RESULT OF A GLASS SHARD PENETRATING THE PLASTIC APPLICATOR OF A CHLORAPREP SEPP APPLICATOR THAT IS INCLUDED IN OUR IV START KITS." THE COMPLAINT STATES THAT THE NURSE DID NOT ACTIVATE THE APPLICATOR STICK ANY DIFFERENTLY THAN PREVIOUSLY. THE HOSPITAL CLARIFIED WITH MAI THAT THE BREAKAGE OCCURRED DURING THE INITIATION OF THE APPLICATOR; THE APPLICATOR WAS NOT BROKEN UPON RECEIPT. ON (B)(6) 2015, MAI ASKED ADDITIONAL INVESTIGATION QUESTIONS TO THE HOSPITAL AS PART OF THE INCIDENT INVESTIGATION AND AT THIS TIME THE HOSPITAL INDICATED THAT TWO OTHER SIMILAR INSTANCES HAD OCCURRED IN THE LAST 3 MONTHS INVOLVING TWO OTHER CHLORAPREP SEPP ONE-STEP APPLICATORS CAUSING SIMILAR INJURIES TO A TOTAL OF TWO DIFFERENT NURSES. THE HOSPITAL REPORTED THAT BOTH NURSES SUSTAINED INJURIES WHEN GLASS SHARDS PUNCTURED THE PLASTIC APPLICATOR UPON ACTIVATION. THE GLASS SHARDS PUNCTURED EACH NURSE'S THUMB CAUSING BLEEDING. EACH EXCUSED HIM/HERSELF FROM PATIENT CARE, REMOVED THEIR GLOVES, AND PROCEEDED WITH BASIC FIRST AID MEASURES WHICH INCLUDED CLEANING THE PUNCTURE SITE, INSPECTING THE INJURY, AND PLACING A BAND-AID ON THE THUMB. THE HOSPITAL REPORTED THAT BOTH NURSES RECOVERED FROM THEIR INJURIES. THE HOSPITAL WAS UNABLE TO CONFIRM THAT THE TWO OTHER INCIDENTS WERE CHLORAPREP SEPP APPLICATORS WHICH WERE ASSEMBLED IN MAI MANUFACTURED KITS. THE HOSPITAL WAS NOT ABLE TO PROVIDE SPECIFIC LOT, CATALOG OR MODEL NUMBER INFORMATION FOR THESE COMPLAINTS; THEREFORE, WE ARE INCLUDING THIS INFORMATION IN ONE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616623 IV START KIT IV START KIT LRS MEDICAL ACTION INDUSTRIES 68917 205539

    Patients

    Seq Age Sex Outcome Treatment
    1 Other