MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA DIFFUSICS; PERIPHERAL IV CATHETERS

Catalog Number	383592
Medical Device Problem Codes	Difficult to Remove (1528); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd nexiva diffusics needle did not disengage.The following information was provided by the initial reporter: iv insertion patient required two ivs related to a high heart rate and sedation procedure.During insertion of 2nd iv, the iv with inserted and upon receiving a flash of blood, the catheter was being threaded while withdrawing the needle, during withdrawl of the needle approximaetly 0.5" of the needle would withdraw but it would not withdraw/disengage from device.
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Additional Manufacturer Narrative
Our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of needle disengagement difficult was confirmed upon inspection of the photo.In the image it is not possible to clearly observe the presence of the catheter in the indicated section of the photo.However, bd cannot confirm the cause of the failure since no sample was returned for evaluation.We would be very interested in examining product that does not meet your expectations and our quality standards.Examination of the actual product involved may provide clarification as to the cause of the reported failure.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.We regret any inconveniences this incident may have caused you and your facility.
Event or Problem Description
Material#: 383592, lot#: 3214181.It was reported by customer that patient required two ivs related to a high heart rate and sedation procedure.During insertion of 2nd iv, the iv with inserted and upon receiving a flash of blood, the catheter was being threaded while withdrawing the needle, during withdrawal of the needle approximately 0.5" of the needle would withdraw but it would not withdraw/disengage from device.Iv insertion: patient required two ivs related to a high heart rate and sedation procedure.During insertion of 2nd iv, the iv with inserted and upon receiving a flash of blood, the catheter was being threaded while withdrawing the needle, during withdrawal of the needle approximately 0.5" of the needle would withdraw but it would not withdraw/disengage from device.Customer response on (b)(6) 2024: i wanted to follow up from what i found and where we are in the process of the product concern.I spoke to melissa regarding the iv site below.Unfortunately as i stated yesterday the staff did not keep the product , but with the picture and speaking to the resource nurse who was involved with this patient, (b)(6) and the iv team , they came to the same conclusion that the vascular x-ray had shown that there was no catheter left inside the patient vessel.I have circled the area and you can view the catheter was attached to the old dressing.The resource nurse stated ¿the iv was lying on top of the skin and not in the vessel upon removal.¿ (b)(6) and i spoke and she stated¿ it was very evident that this iv was lacking care and maintenance.¿ (b)(6) stated¿ this patient was in house for several days and the same iv was in during her stay.¿ the iv was a saline lock and no iv fluids were running through it.Second, i spoke to (b)(6) and received the device that malfunctioned.(b)(6) told me that the nurse was unable to retract the entire needle back, therefore , he had to restart the site.(b)(6) stated¿ they have never had issues with the nexiva diffusus and feels it was a ¿one off.¿ i am unable to test this product, but i will send it in for evaluation by the bd product complaint team.Currently, (b)(6) did complete a product incident report (pir) and forwarded to the team.Once we receive from the proper team who will be following up , i will send in for evaluation.Please allow time for the evaluation.They will reach out to (b)(6) with the report out.Once received he will communicate to you.(b)(6), thank you for letting us know of the issues and allowing me to talk to the individuals involved.Unfortunately, i was not able to speak to the nurse since she no longer works at (b)(6) center.

• Brand Name: BD NEXIVA DIFFUSICS
• Common Device Name: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales UT ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18997563
• Report Number: 9610847-2024-00072
• Device Sequence Number: 8203967
• Product Code: FOZ
• UDI-Device Identifier: 00382903835928
• UDI-Public: (01)00382903835928
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K173354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2024

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 Expiration Date: 07/31/2026
• Device Catalogue Number: 383592
• Device Lot Number: 3214181
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2024
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown