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U.S. Department of Health and Human Services

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

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. NEXIVA DIFFUSICS 22G X 1.00 IN INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383591
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Extravasation (1842)
Event Date 04/18/2021
Event Type  Injury  
Manufacturer Narrative
Date of birth: unknown. The patient¿s age was used to determine a placeholder date for this field. Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident. 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 Description
It was reported that extravasation occurred while using nexiva diffusics 22g x 1. 00 in. The patient had to get a skin graft. The following information was provided by the initial reporter: material no: 383591 batch no: unknown it was reported an extravasation occurred, patient had to go to surgery to get skin graft due to infiltration. Verbatim: 22g diffusics was placed in the right forearm by ed rn on (b)(6). Rn said he got good blood return and good flush. An extravasation occurred once the patient went to ct to get contrast. The auto-injector was set as 300 psi. Patient had to go to surgery to get skin graft due to infiltration.
 
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Brand NameNEXIVA DIFFUSICS 22G X 1.00 IN
Type of DeviceINTERVASCULAR 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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11845993
MDR Text Key260925847
Report Number9610847-2021-00218
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173354
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue Number383591
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/18/2021 Patient Sequence Number: 1
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