MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA DIFFUSICS 20G X 1.00 IN; INTRAVASCULAR CATHETER

Catalog Number 383592

Device Problem Difficult or Delayed Activation (2577)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd nexiva diffusics 20g x 1.00 in needle disengagement was difficult the following information was provided by the initial reporter: it was reported by the customer that the removal of the needle from the iv catheter the needle got stuck at the base of the catheter and could not be fully removed.Verbatim: 2682-pc - (b)(6) , rn went to insert an iv per primary rns instruction.Iv diffusics nexiva 20 g was utilized and inserted successfully.However, during the removal of the needle from the iv catheter the needle got stuck at the base of the catheter and could not be fully removed.The whole iv had to be removed from the patient as needled could not be fully retrieved.(b)(6) , rn pulled primary rn ((b)(6) ) to room to be a second witness.Once the iv was removed the patient had to undergo additional iv start attempts due to this mechanical failure.

Event Description

Response received.0n 24th jan 24.Thanks for following up.I¿m including liliana to this email chain who can help assist with your questions.Lili ¿ this is the team who is investigating the product concern regarding the iv catheter.Can you help answer the questions below? hello, 1.How was the patient outcome? are there any clinical signs, health consequences or impact? there was no health consequences, patient had to be poked several more times due to this product malfunction, but she was not affected otherwise.2.Any adverse event or serious injury reported to patient or health care professional? no.3.Are you able to provide the address of the facility for us to ship the return label? this is the hospital's address (b)(6).

Manufacturer Narrative

A device history record review was completed by our quality engineer team for provided material number 383592 and lot number 3214181.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD NEXIVA DIFFUSICS 20G X 1.00 IN
• Type of Device: INTRAVASCULAR CATHETER
• 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: 18587908
• MDR Text Key: 334840328
• Report Number: 9610847-2024-00011
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835929
• UDI-Public: (01)30382903835929
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 383592
• Device Lot Number: 3214181
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 01/26/2024
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1