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
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd nexiva diffusics 20g x 1.00 in leaked it was reported by customer that bd nexiva diffusics 20g closed iv catheter system used to start iv on pt for contrast administration during ct scan, unable to use initial site as catheter was faulty, having holes in catheter on proximal end instead of just distal end where they're designed to be, causing iv to leak and pt to bleed from iv site while iv was still inserted.Second iv started on pt without complications.Verbatim: complaint received via email(s) attached.Rcc received a complaint via email.Email(s) attached bd nexiva diffusics 20g closed iv catheter system used to start iv on pt for contrast administration during ct scan, unable to use initial site as catheter was faulty, having holes in catheter on proximal end instead of just distal end where they're designed to be, causing iv to leak and pt to bleed from iv site while iv was still inserted.Second iv started on pt without complications.No complications request a return label-please e-mail to me.(b)(6).Nexiva diffusics iv catheter sample will be sent by customer email unknown or.
Additional Manufacturer Narrative
Investigation results: a device history record review was completed by our quality engineer team for provided material number 383592 and lot number 3355391.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.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.
Event or Problem Description
No additional information.

• Brand Name: BD NEXIVA DIFFUSICS 20G X 1.00 IN
• Common Device Name: 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: 20253017
• Report Number: 9610847-2024-00269
• Device Sequence Number: 8667236
• Product Code: FOZ
• UDI-Device Identifier: 00382903835928
• UDI-Public: (01)00382903835928
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2025

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: 383592
• Device Lot Number: 3355391
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2024
• Supplement Date Received by Manufacturer: 01/20/2025
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown