MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA; INTRAVASCULAR CATHETER

Catalog Number 383667

Device Problem Separation Problem (4043)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/12/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.3 total occurrences for this failure described.1 with known event date and patient outcome information.Two without known event date and no patient outcome information provided.

Event Description

It was reported that bd nexiva needle disengagement is difficult.The following information was provided by the initial reporter translated from dutch to english: supposedly due to stock breakage, we are currently getting an alternative for our nexiva catheters.Problems: - when we puncture and we remove the needle, sometimes blood leaks during blood collection from the grey eraser through which the needle is removed (see photo).- the needle sometimes sticks to the eraser and so we do not get it completely removed.- when injecting, the fluid or medicine also gets past the eraser.As a result, patient had to be re-pricked to have safe medication access and avoid infection risk.Can this be taken up with bd supplying these catheters? so should we not use this alternative anyway or should we stand by and list how frequently it occurs? or have there been any reports? these three problems occurred at many intervals (one as recently as december, one a week ago, one today) but it may also have often gone unreported or reached us.So it cannot be from the same box either given our high consumption.

Event Description

Mail received date: 26-feb-2024 (b)(6).Could you please confirm the date of the events? first notification january.Second notification 31 january.Third notification 10 february.Could you please also confirm the number of incidents? 3 we know about.Could you please confirm the date of awareness? on 10 february, a report was made via the prevention and protection service.I have tried to formulate an answer to the company's questions about the problems with the currently used nexiva catheters.Can you send it to the company in question? (b)(6).When was the problem identified (before use on the patient, during preparation for use, or during use)? needle stuck in catheter, could not be removed from catheter: the problem in our department was diagnosed when the catheter was placed.Gray gummy did not stop properly, patient's blood leaked down the gummy.Also when spraying physiological water, moisture came along the gummy.Did the defect result in serious injury? the defect caused both patients to have to be re-pricked because the primary catheter had a defect.This was not experienced as pleasant by the patients.Did the treatment plan need to be adjusted as a result of this incident? a new injection attempt was made, for the placement of an iv access in order to be able to safely give the full dose of medication.Did any medical intervention need to be carried out as a result of this incident? no.Did any other actions need to be taken as a result of the defect? removal of the defective catheter, care for and covering of the insertion point.Can you indicate whether the samples unused (before use): used (during or after use): the catheters were taken out of a sealed package for insertion, defective was found during use.Important: if used, confirm if the samples have been used or contaminated with blood or cytotoxic medications.The catheters are only contaminated with blood.Also provide us with the full pick-up address, the name and number of the contact person, the name of the department, the floor number and any additional details such as (pick-up at the reception, goods in the courtyard, etc.If it is not possible to return the sample, can you provide detailed photos of the product in question? the photo of the leaking catheter would have already been obtained from our purchasing department.Mail received date: 05-mar-2024.No sample collection possible as the box will be gone.

Manufacturer Narrative

A device history record review was completed by our quality engineer team for provided material number: 383667 and lot number: 3060977.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
• 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 ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18828820
• MDR Text Key: 336868083
• Report Number: 9610847-2024-00051
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903836673
• UDI-Public: (01)00382903836673
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K102520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• 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

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 383667
• Device Lot Number: 3060977
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1