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

Catalog Number	383593
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	04/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd nexiva¿ diffusics¿ closed iv catheter system caused extravasation in the patient during the ct exam.This complaint was created to capture the 1st of 3 related incidents.The following information was provided by the initial reporter: "caller states they recently switched to the nexiva diffusics and over the last month have had about 7 extravasation.They are able to draw blood and flush with out issues.When they power inject the patient appears fine and not in pain, but the evaluation of the iv site after shows extravasation.She is unclear if it is a placement issue or issue with the catheter.I honestly do not know this information as its charted in the patients charts and did not keep a list of the patient's names until now.The exams were ct¿s the exams for the most part were scanned as a without contrast because there was no contrast in the images on 2 of them, i would say 2 or 3 of them were stopped and we were able to start another iv and continue with the contrast that was left and one of the exams was injected the entire amount and the radiologist approved us to start a new iv and inject in the other arm to complete the scan, and 2 or 3 were rescheduled.No serious injury really.".
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Additional Manufacturer Narrative
Since no photos or samples displaying the reported condition of leakage were available for examination, we were unable to fully investigate this incident.A device history review could not be completed as no batch number was provided.H3 other text : see h10.
Event or Problem Description
It was reported that the bd nexiva¿ diffusics¿ closed iv catheter system caused extravasation in the patient during the ct exam.This complaint was created to capture the 1st of 3 related incidents.The following information was provided by the initial reporter: "caller states they recently switched to the nexiva diffusics and over the last month have had about 7 extravasation.They are able to draw blood and flush with out issues.When they power inject the patient appears fine and not in pain, but the evaluation of the iv site after shows extravasation.She is unclear if it is a placement issue or issue with the catheter.I honestly do not know this information as its charted in the patients charts and did not keep a list of the patient's names until now.The exams were ct¿s the exams for the most part were scanned as a without contrast because there was no contrast in the images on 2 of them, i would say 2 or 3 of them were stopped and we were able to start another iv and continue with the contrast that was left and one of the exams was injected the entire amount and the radiologist approved us to start a new iv and inject in the other arm to complete the scan, and 2 or 3 were rescheduled.No serious injury really.".

• Brand Name: BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16894748
• Report Number: 9610847-2023-00103
• Device Sequence Number: 6091825
• Product Code: FOZ
• UDI-Device Identifier: 00382903835935
• UDI-Public: 00382903835935
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K173354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 383593
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown