BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER 20GA 1.16IN (1.1 X 30 MM)

    MDR report key: 10112166 · Received June 2, 2020

    Report

    Report Number
    1710034-2020-00347
    Event Type
    Injury
    Date Received
    June 2, 2020
    Date of Event
    May 9, 2020
    Report Date
    June 30, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814344
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE REPRESENTATIVE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED 652 SAMPLES FROM LOT NUMBER 0031666 AND 1 SAMPLE FROM LOT NUMBER 0044105. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THESE BATCHES. A REVIEW OF OUR COMPLAINT HISTORY SHOWS THAT THESE ARE THE FIRST REPORTED ISSUES WITH THIS DEFECT REPORTED FOR THESE LOT NUMBERS. SINCE THE ACTUAL UNIT HAS NOT BEEN RETURNED FOR OBSERVATION, TESTING WILL BE CONDUCTED FOR A REPRESENTATIVE SAMPLING OF THE PRODUCT RECEIVED. A VISUAL/MICROSCOPIC INSPECTION WAS PERFORMED ON THE 153 UNITS BEFORE THE TEST. THERE WERE NO SIGNS OF BENDS, HOLES, KINKS, SPLITS, OR WRINKLES NOR THE CHARACTERISTIC V SHAPE OF A SPEAR THRU IN THE ANY OF THE CATHETER TUBING OF THE RETURNED UNITS. A CATHETER/ADAPTER PULL TEST WAS PERFORMED. ALL SAMPLES TESTED WITHIN THE SPECIFICATION. THE RETURNED UNITS PROVIDED FOR EVALUATION MET AND PERFORMED PER THE REQUIRED MANUFACTURING SPECIFICATIONS. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURES STATED IN THE REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 20GA 1.16IN (1.1 X 30 MM) SEPARATED FROM THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT THE CATHETER BROKE OFF WHILE INSIDE THE PATIENT. PER CUSTOMER RESPONSE: WHAT IS THE MATERIAL AND/OR LOT NUMBER TO THE CATHETER YOU HAD ISSUES WITH? 20G IV, LOT #0031666. CAN YOU DESCRIBE THE ISSUE YOU HAD WITH THE CATHETER? THE CATHETER BROKE OFF WHILE INSIDE THE PATIENT. WHAT IS THE DATE OF THE EVENT? (B)(6) 2020. DID THE ISSUE OCCUR BEFORE, DURING OR AFTER USE? DURING. WAS THERE SERIOUS INJURY? NO. WERE THERE ERRONEOUS RESULTS? NO. DID THE COURSE OF TREATMENT CHANGE? NO. WAS THERE EXPOSURE TO BLOOD/BODILY FLUID? NO EXPOSURE, ALL PPE WAS USED CORRECTLY. WAS THERE MEDICAL INTERVENTION? YES. WERE THERE ANY OTHER ACTIONS TAKEN? YES. THE ER PHYSICIAN HAD TO CUT INTO THE PATIENT TO REMOVE THE CATHETER. ARE SAMPLES AVAILABLE FOR INVESTIGATION? YES.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 20GA 1.16IN (1.1 X 30 MM) SEPARATED FROM THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT THE CATHETER BROKE OFF WHILE INSIDE THE PATIENT. PER CUSTOMER RESPONSE: WHAT IS THE MATERIAL AND/OR LOT NUMBER TO THE CATHETER YOU HAD ISSUES WITH? 20G IV, LOT #0031666. CAN YOU DESCRIBE THE ISSUE YOU HAD WITH THE CATHETER? THE CATHETER BROKE OFF WHILE INSIDE THE PATIENT: WHAT IS THE DATE OF THE EVENT? (B)(6) 2020. DID THE ISSUE OCCUR BEFORE, DURING OR AFTER USE? DURING. WAS THERE SERIOUS INJURY? NO. WERE THERE ERRONEOUS RESULTS? NO. DID THE COURSE OF TREATMENT CHANGE? NO. WAS THERE EXPOSURE TO BLOOD/BODILY FLUID? NO EXPOSURE, ALL PPE WAS USED CORRECTLY. ¿ WAS THERE MEDICAL INTERVENTION? YES. WERE THERE ANY OTHER ACTIONS TAKEN? YES. THE ER PHYSICIAN HAD TO CUT INTO THE PATIENT TO REMOVE THE CATHETER. ARE SAMPLES AVAILABLE FOR INVESTIGATION? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571476 BD INSYTE AUTOGUARD SHIELDED IV CATHETER 20GA 1.16IN (1.1 X 30 MM) INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381434 0031666 30382903814344

    Patients

    Seq Age Sex Outcome Treatment
    1 Other