MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOG BC; PERIPHERAL IV CATHETERS

Catalog Number	392623
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Address information was not provided, therefore, xx was used as a place holder.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that a bd insyte autog bc grn 18ga x 1.16in catheter cracked.The following information was provided by the initial reporter: patients have to have iv's replaced because they are going bad.Many of those are due to catheter damage.On many of them the catheter will crack right next to the hub causing them to leak under the dressing.Patients are having to be stuck 5-6 times each time they need to replace an iv.: hello (b)(6), so over the past few weeks, i have noticed that i personally have had a big increase in the number of iv's that are going bad on my shift.There have been a couple days where 3 of my 5 patients have to have iv's replaced because they are going bad.Many of those are due to catheter damage.On many of them the catheter will crack right next to the hub causing them to leak under the dressing.In addition, i have noticed that the iv supplies that we are using are not great.They are very difficult to insert.I am not sure how to put it, but it almost feels like they catheter won't slide again the skin.It just sticks to is like it needs lubricated to slide into the skin.Compared to the materials that i used at bathesda north, i've never had so much trouble placing an iv.The iv needles that were used at bathesda were very smooth.You would insert the needle until you got blood return then you could "flick" with your pointer finger and advance the catheter.The needles we have on the floor, once you get blood return, it is like you have to use the needle to force the catheter the rest of the way into the vein.This causes many of us to blow the veins and leads up to need to call for us to place them.I've talked to many nurses throughout the hospital and on 4 main and all are seeming to have this same experience.In relation to this, i am wondering if this is also affecting our patient experience scores.I, for one, hate being stuck.Many of our patients are having to be stuck 5-6 times each time they need to replace an iv, which is also happening more and more often.I would certainly have strong words for the hospital if i had to have repeated sticks while there.I am spoken with elle, the educator about this and she is going to follow up about the materials.She placed a few iv's on the floor during day shift today and also stated that the materials seemed cheap and not user friendly.If there is any way that i can help with this any further, please let me know.I would love to have products that are easier to place and to regain my confidence in placing iv's as it used to be one of my favorite nursing skills.Thanks for your time and for listening.

• Brand Name: BD INSYTE AUTOG BC
• Common Device Name: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18595912
• Report Number: 1710034-2024-00045
• Device Sequence Number: 20481718
• Product Code: FOZ
• UDI-Device Identifier: 00382903926237
• UDI-Public: (01)00382903926237
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 392623
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown