BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY

    MDR report key: 10071143 · Received May 19, 2020

    Report

    Report Number
    1710034-2020-00315
    Event Type
    Malfunction
    Date Received
    May 19, 2020
    Date of Event
    May 1, 2020
    Report Date
    June 18, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825234
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY WAS SPLIT WHEN INSERTING INTO THE VEIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 382523 BATCH NO: UNKNOWN. IT WAS REPORTED THAT PLASTIC CATHETER AROUND THE NEEDLE SPLIT AT THE TOP WHEN INSERTING IV INTO VEIN. PER CUSTOMER RESPONSE 05/04/2020 ¿ HOW MANY TIMES HAS THE INCIDENT OCCURRED? WHEN WE FIRST STARTED USING THIS PRODUCT WE HAVE THIS HAPPEN QUITE OFTEN. THESE ARE THE FIRST TWO THAT HAVE BEEN REPORTED. ¿ ARE YOU ABLE TO PROVIDE DATES AND/OR PATIENT IDENTIFIERS? FOR THE 20GA X 1.16 PRODUCT # 382534 IT WAS ON (B)(6)2020 ¿ THE 22GA X 1 IN PRODUCT # 382523, I HAVE NO LOT # FOR THIS ONE THEY DIDN¿T SAVE THE PACKAGE. NO PATIENT HARM WITH EITHER OF THESE. ¿ WERE THERE ERRONEOUS RESULTS? N/A ¿ WAS THERE EXPOSURE TO BLOOD/BODILY FLUID? N/A ¿ ARE SAMPLES AVAILABLE FOR INVESTIGATION? YES I HAVE BOTH OF THESE CATHETERS THAT I CAN SEND BACK. D.1. MEDICAL DEVICE BRAND NAME: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY. H.6. FDA DEVICE PROBLEM CODE: 1354. H.6. FDA PATIENT PROBLEM CODE: 2199

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED ONE RETRACTED UNIT AND A CATHETER ADAPTER ASSEMBLY. A MICROSCOPIC INSPECTION OF THE CATHETER TUBING WAS PERFORMED. A V-SHAPE FROM WHEN THE NEEDLE SPEARED THROUGH THE CATHETER WALL WAS OBSERVED. THE REPORTED ISSUE WAS OBSERVED AS THE NEEDLE SPEARED THROUGH THE CATHETER TUBING WALL. ALTHOUGH THE REPORTED ISSUE WAS CONFIRMED, IT COULD NOT BE DETERMINED IF THE DAMAGE RESULTED FROM THE MANUFACTURING OF THE DEVICE OR FROM THE USER ENVIRONMENT. BASED ON THE VERBATIM IN THE REPORT ¿IT WAS REPORTED THAT PLASTIC CATHETER AROUND THE NEEDLE SPLIT AT THE TOP WHEN INSERTING IV INTO VEIN¿, IT CAN BE ASSUMED THAT THE DAMAGE TO THE CATHETER TIP OCCURRED WHILE ATTEMPTING VENIPUNCTURE. A DHR REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS ¿UNKNOWN¿ FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY WAS SPLIT WHEN INSERTING INTO THE VEIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 382523 BATCH NO: UNKNOWN. IT WAS REPORTED THAT PLASTIC CATHETER AROUND THE NEEDLE SPLIT AT THE TOP WHEN INSERTING IV INTO VEIN. PER CUSTOMER RESPONSE 05/04/2020 ¿ HOW MANY TIMES HAS THE INCIDENT OCCURRED? WHEN WE FIRST STARTED USING THIS PRODUCT WE HAVE THIS HAPPEN QUITE OFTEN. THESE ARE THE FIRST TWO THAT HAVE BEEN REPORTED. ¿ ARE YOU ABLE TO PROVIDE DATES AND/OR PATIENT IDENTIFIERS? FOR THE 20GA X 1.16 PRODUCT # 382534 IT WAS ON MARCH 30,2020 ¿ THE 22GA X 1 IN PRODUCT # 382523, I HAVE NO LOT # FOR THIS ONE THEY DIDN¿T SAVE THE PACKAGE. NO PATIENT HARM WITH EITHER OF THESE. ¿ WERE THERE ERRONEOUS RESULTS? N/A ¿ WAS THERE EXPOSURE TO BLOOD/BODILY FLUID? N/A ¿ ARE SAMPLES AVAILABLE FOR INVESTIGATION? YES I HAVE BOTH OF THESE CATHETERS THAT I CAN SEND BACK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY WAS SPLIT WHEN INSERTING INTO THE VEIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 382523 BATCH NO: UNKNOWN IT WAS REPORTED THAT PLASTIC CATHETER AROUND THE NEEDLE SPLIT AT THE TOP WHEN INSERTING IV INTO VEIN. PER CUSTOMER RESPONSE 05/04/2020: HOW MANY TIMES HAS THE INCIDENT OCCURRED? WHEN WE FIRST STARTED USING THIS PRODUCT WE HAVE THIS HAPPEN QUITE OFTEN. THESE ARE THE FIRST TWO THAT HAVE BEEN REPORTED. ARE YOU ABLE TO PROVIDE DATES AND/OR PATIENT IDENTIFIERS? FOR THE 20GA X 1.16 PRODUCT # 382534 IT WAS ON (B)(6) 2020 ¿ THE 22GA X 1 IN PRODUCT # 382523, I HAVE NO LOT # FOR THIS ONE THEY DIDN¿T SAVE THE PACKAGE. NO PATIENT HARM WITH EITHER OF THESE. WERE THERE ERRONEOUS RESULTS? N/A. WAS THERE EXPOSURE TO BLOOD/BODILY FLUID? N/A. ARE SAMPLES AVAILABLE FOR INVESTIGATION? YES. I HAVE BOTH OF THESE CATHETERS THAT I CAN SEND BACK.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE BRAND NAME: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 22GA 1.00IN (0.9 X 25 MM). DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 · 1

    IT WAS REPORTED THAT A SPLIT CATHETER OCCURRED DURING USE WITH A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 22GA 1.00IN (0.9 X 25 MM). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "STARTING IV WITH BD INSYTE AUTOGUARD BC PLASTIC CATHETER AROUND NEEDLE SPLIT AT TOP WHEN INSERTING IV INTO VEIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536843 BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 382523 UNKNOWN 30382903825234

    Patients

    Seq Age Sex Outcome Treatment
    1 Other