BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA

    MDR report key: 17148373 · Received June 16, 2023

    Report

    Report Number
    1710034-2023-00688
    Event Type
    Malfunction
    Date Received
    June 16, 2023
    Date of Event
    May 23, 2023
    Report Date
    August 16, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814237
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY : OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED TWO PHOTOGRAPHS WITH PHOTO 1 DISPLAYING THE TOP WEB LABEL INFORMATION INDICATING THE DEVICE IS A 20G INSYTE AUTOGUARD BC CATHETER ASSEMBLY FROM LOT NUMBER 3030423, MATERIAL NUMBER 382533. IN THE REPORT, IT STATED THAT ¿RECENTLY DISCOVERED SOME CONCERNING PRODUCT DEFECTS WITH OUR 20G IV CATHS SPECIFICALLY. LOT 3030426 / 2023-02-01 / EXP 2023-01-31¿. AS MATERIAL NUMBER 382533 (20G) DOES NOT ALIGN WITH LOT NUMBER 3030426 AND THE PHOTO YOU PROVIDED DISPLAYS THE LABEL CONFIRMING LOT NUMBER 3030423, WE HAVE INVESTIGATED THE REPORT FOR THE 20G UNIT FROM MATERIAL NUMBER 382533, LOT NUMBER 3030423. PHOTO 2 DISPLAYS THE CATHETER TUBING AT THE CATHETER TIP APPEARING BENT AND A TEAR CAN BE SEEN ON THE RIGHT SIDE OF THE TUBING AT THE ORIGIN POINT OF THE BEND. THE FEATURES EXHIBITED IN THE PHOTOGRAPHED UNIT ARE INDICATIVE OF A NEEDLE SPEAR THROUGH. AS THE UNIT IS OPENED, IT IS POSSIBLE THAT THE DAMAGE ORIGINATED DURING MANUFACTURING OR DURING USE. DURING MANUFACTURING, A SPEAR THROUGH MAY OCCUR DUE TO MISALIGNMENT OF THE SET TOGETHER STATION, BENT TUBING, OR AIR BLOW INCONSISTENCY. THERE IS A 100 PERCENT AUTOMATED VISION SYSTEM INSPECTION AND A SAMPLING PLAN IMPLEMENTED FOR TIP SPEAR AND LIE DISTANCE, WHICH MITIGATES THE OCCURRENCE OF THIS DEFECT. THE DAMAGE MAY ALSO OCCUR IN THE CLINICIAN SETTING DURING TIP ADHESION BREAK IF THE NEEDLE IS MOVED UP AND DOWN THE CATHETER TUBING.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA THE CATHETER WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECENTLY DISCOVERED SOME CONCERNING PRODUCT DEFECTS WITH OUR 20G IV CATHS SPECIFICALLY. LOT 3030426 / 2023-02-01 / EXP 2023-01-31 WE ARE SUPPOSED TO BE ORDERING THIS FROM MEDLINE BUT USE MCK SO I AM NOT ABLE TO INCLUDE CORP TO KNOW IF THIS IS SOMETHING HAPPENING ALL AROUND OR WHAT- BUT THIS IS NOT GOOD. MCKESSON CALLED AND STATED THE NEEDLES ARE BENT ADDITIONAL INFO RECEIVED ON 07-JUNE-23. DID THE NEEDLE RECEIVE IN THE CONDITION? OPENED PACKAGE AND NOTICED THE CATH PLASTIC WAS SPLIT. WAS THE NEEDLE USED ON PATIENT? IF YES, ANY IMPACTED TO THE PATIENT? YES, WE USED 3 IN TOTAL AND RECOGNIZED ALL CAME FROM THE SAME LOT #. NI IMPACT AS STAFF TOOK GREAT CARE IN REMOVING IV CATH CAREFULLY WITHOUT INCIDENT. ARE YOU ABLE TO PROVIDE QUANTITY AFFECTED? WE HAD 10 CATH BOXES OF THAT LOT # THAT MCK REPLACED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA THE CATHETER WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECENTLY DISCOVERED SOME CONCERNING PRODUCT DEFECTS WITH OUR 20G IV CATHS SPECIFICALLY. LOT 3030426 / 2023-02-01 / EXP 2023-01-31. WE ARE SUPPOSED TO BE ORDERING THIS FROM MEDLINE BUT USE MCK SO I AM NOT ABLE TO INCLUDE CORP TO KNOW IF THIS IS SOMETHING HAPPENING ALL AROUND OR WHAT- BUT THIS IS NOT GOOD. MCKESSON CALLED AND STATED THE NEEDLES ARE BENT. ADDITIONAL INFO RECEIVED ON 07-JUNE-23. DID THE NEEDLE RECEIVE IN THE CONDITION? OPENED PACKAGE AND NOTICED THE CATH PLASTIC WAS SPLIT. WAS THE NEEDLE USED ON PATIENT? IF YES, ANY IMPACTED TO THE PATIENT? YES, WE USED (B)(4) IN TOTAL AND RECOGNIZED ALL CAME FROM THE SAME LOT #. NI IMPACT AS STAFF TOOK GREAT CARE IN REMOVING IV CATH CAREFULLY WITHOUT INCIDENT. ARE YOU ABLE TO PROVIDE QUANTITY AFFECTED? WE HAD (B)(4) CATH BOXES OF THAT LOT # THAT MCK REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692292 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381423 3030426 00382903814237

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown