BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8524385 · Received April 17, 2019

    Report

    Report Number
    2243072-2019-00745
    Event Type
    Malfunction
    Date Received
    April 17, 2019
    Date of Event
    February 2, 2019
    Report Date
    May 22, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903815112
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: SITE LEGAL NAME (FDA): SANDY, UT / 84070. D.3. MEDICAL DEVICE MANUFACTURER: SANDY. G.1. MANUFACTURING LOCATION: SANDY.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. REVIEW DISCLOSED NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT. WITHOUT THE ACTUAL SAMPLE FOR EVALUATION AND TESTING THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER WAS CRACKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381511. BATCH NO.: 8275532. IT WAS REPORTED THAT THE ANGIOCATH WAS NOT ABLE TO BE STARTED DUE TO QUALITY ISSUES. IT WAS ALSO REPORTED THAT THE CATHETER WAS CRACKED. IT WAS CLARIFIED THAT THE BEVEL AREA OF THE CATHETER TIP IS BUBBLED. IT WAS ALSO REPORTED THAT THERE IS DIFFICULTY PENETRATING THE SKIN, NO OR VERY LITTLE FLASHBACK, AND VEINS ARE BLOWING. THIS COMPLAINT IS FOR PATIENT (B)(6) ON (B)(6)2019. "CATH IV AUTOGRD 24GA .56IN. FIVE 24 GAUGE ANGIOCATHS WERE USED TO TRY AND START AN IV ON A NEW NICU ADMISSION WHERE TIME IS CRITICAL FOR IV ACCESS. SKILLED NURSING, NEONATOLOGIST AND NURSE PRACTITIONER ALL ATTEMPTED TO GET IV ACCESS. UVC HAD TO BE PLACED WHICH IS MORE INVASIVE AND INCREASED RISK FOR INFECTION. PLEASE REVIEW QRR REPORT FOR ALL IV ACCESS ISSUES IN NICU. I WOULD LIKE TO GO BACK TO THE OLD ANGIOCATHS." RESPECTFULLY, I BELIEVE THIS IS A QUALITY ISSUE WITH THE CATHETER ITSELF. WE HAVE HAD A COUPLE OTHER QUALITY REVIEW REPORTS REGARDING THE QUALITY OF THE IV CATHETER AND MANY OTHER ISSUES THAT WERE PROBABLY NOT REPORTED FORMALLY. IN ONE INSTANCE THE IV CATHETER ACTUALLY CRACKED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER WAS CRACKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381511 BATCH NO.: 8275532. IT WAS REPORTED THAT THE ANGIOCATH WAS NOT ABLE TO BE STARTED DUE TO QUALITY ISSUES. IT WAS ALSO REPORTED THAT THE CATHETER WAS CRACKED. IT WAS CLARIFIED THAT THE BEVEL AREA OF THE CATHETER TIP IS BUBBLED. IT WAS ALSO REPORTED THAT THERE IS DIFFICULTY PENETRATING THE SKIN, NO OR VERY LITTLE FLASHBACK, AND VEINS ARE BLOWING. THIS COMPLAINT IS FOR PATIENT (B)(6) ON (B)(6) 2019. "CATH IV AUTOGRD 24GA .56IN. FIVE 24 GAUGE ANGIOCATHS WERE USED TO TRY AND START AN IV ON A NEW NICU ADMISSION WHERE TIME IS CRITICAL FOR IV ACCESS. SKILLED NURSING, NEONATOLOGIST AND NURSE PRACTITIONER ALL ATTEMPTED TO GET IV ACCESS. UVC HAD TO BE PLACED WHICH IS MORE INVASIVE AND INCREASED RISK FOR INFECTION. PLEASE REVIEW QRR REPORT FOR ALL IV ACCESS ISSUES IN NICU. I WOULD LIKE TO GO BACK TO THE OLD ANGIOCATHS." RESPECTFULLY, I BELIEVE THIS IS A QUALITY ISSUE WITH THE CATHETER ITSELF. WE HAVE HAD A COUPLE OTHER QUALITY REVIEW REPORTS REGARDING THE QUALITY OF THE IV CATHETER AND MANY OTHER ISSUES THAT WERE PROBABLY NOT REPORTED FORMALLY. IN ONE INSTANCE THE IV CATHETER ACTUALLY CRACKED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER WAS CRACKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381511, BATCH NO.: 8275532. IT WAS REPORTED THAT THE ANGIOCATH WAS NOT ABLE TO BE STARTED DUE TO QUALITY ISSUES. IT WAS ALSO REPORTED THAT THE CATHETER WAS CRACKED. IT WAS CLARIFIED THAT THE BEVEL AREA OF THE CATHETER TIP IS BUBBLED. IT WAS ALSO REPORTED THAT THERE IS DIFFICULTY PENETRATING THE SKIN, NO OR VERY LITTLE FLASHBACK, AND VEINS ARE BLOWING. THIS COMPLAINT IS FOR PATIENT (B)(6) ON (B)(6) 2019. "CATH IV AUTOGRD 24GA .56IN. FIVE 24 GAUGE ANGIOCATHS WERE USED TO TRY AND START AN IV ON A NEW NICU ADMISSION WHERE TIME IS CRITICAL FOR IV ACCESS. SKILLED NURSING, NEONATOLOGIST AND NURSE PRACTITIONER ALL ATTEMPTED TO GET IV ACCESS. UVC HAD TO BE PLACED WHICH IS MORE INVASIVE AND INCREASED RISK FOR INFECTION. PLEASE REVIEW QRR REPORT FOR ALL IV ACCESS ISSUES IN NICU. I WOULD LIKE TO GO BACK TO THE OLD ANGIOCATHS." RESPECTFULLY, I BELIEVE THIS IS A QUALITY ISSUE WITH THE CATHETER ITSELF. WE HAVE HAD A COUPLE OTHER QUALITY REVIEW REPORTS REGARDING THE QUALITY OF THE IV CATHETER AND MANY OTHER ISSUES THAT WERE PROBABLY NOT REPORTED FORMALLY. IN ONE INSTANCE THE IV CATHETER ACTUALLY CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317483 BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8275532 30382903815112

    Patients

    Seq Age Sex Outcome Treatment
    1 Other