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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 20 GA 1.75 IN INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 20 GA 1.75 IN INTRAVASCULAR CATHETER Back to Search Results
Model Number 383538
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Date 03/10/2020
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that an unspecified number of bd nexiva¿ closed iv catheter systems - dual port 20 ga 1. 75 in were involved in a serious injury in the form of a change in the course of treatment during use. Due to painful application, multiple patients have requested to have the placement of their iv stopped. It has not been specified whether alternative medical treatment/intervention was sought or received as a result. The following information was provided by the initial reporter: material no. : 383538, batch no. : 9325212. Per email: so i just messed with the 20g. It feels like there's a little lip on the tip of the needle. If you run something over the tip you can feel it catch. It's not like that on the 22's. Nexiva needles 20g 1. 75" have been really dull lately. Last few boxes we've had. The lot number 9325212. Help!!!! this isn't ok for our vets! very painful for the patient. Multiple have requested stopping the placement of iv.
 
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Brand NameBD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 20 GA 1.75 IN
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer (Section G)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key9923844
MDR Text Key188327438
Report Number1710034-2020-00241
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K183399
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number383538
Device Catalogue Number383538
Device Lot Number9325212
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/26/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/21/2019
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: 04/03/2020 Patient Sequence Number: 1
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