MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA DIFFUSICS 22G X 1.00 IN; INTRAVASCULAR CATHETER

Catalog Number 383591

Device Problem Activation Problem (4042)

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

Event Date 03/21/2024

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 the bd nexiva diffusics 22g x 1.00 in had a safety shield activation failure (catheter).The following information was provided by the initial reporter: it was reported by customer that 2 instances (b)(6) 2024 & (b)(6) 2024 of safety mechanism engaging fully, but not able to disconnect from iv catheter.Had to remove iv from patient and replace at different iv site.Additional information provided on 04/01/2024: i do not have a physical sample, however, i did send a picture.Did you receive it? i did try to figure out what the malfunction was and was able to forcibly disconnect the needle lock device from the iv catheter by twisting and pulling fairly hard.¿ any adverse event or serious injury reported to patient or healthcare professional? no ¿ any physical sample or photo available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? only a photo ¿ can you please provide more details and describe how the product is damaged.See above ¿ please confirm whether there was any patient impact.Only a delay to exam and an inconvenience to patient being stuck again.

Manufacturer Narrative

Our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of safety shield activation failure (catheter) was confirmed upon inspection of the photo.The inspection of the photo found that the safety device was not completely activated.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 Description

No additional information.

• Brand Name: BD NEXIVA DIFFUSICS 22G 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): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; colosio no. 579; sandy UT 84070
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19101450
• MDR Text Key: 340802982
• Report Number: 9610847-2024-00088
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835911
• UDI-Public: (01)00382903835911
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 383591
• Device Lot Number: 3270891
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1