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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 22GA 1.00IN CONNECTA W/ Q-SYTE INTRAVASCULAR CATHETER

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. NEXIVA 22GA 1.00IN CONNECTA W/ Q-SYTE INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383662
Device Problem Difficult to Remove (1528)
Patient Problem No Information (3190)
Event Date 03/26/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation and/or device history review, a supplemental report will be filed.
 
Event Description
It was reported that during use of the nexiva 22ga 1. 00in connecta w/ q-syte the filter cannot be removed it is to tight. Foreign complaint the following information was provided by the initial reporter, translated from (b)(6) to english: when they put in the nexiva, and they want to remove the filter, they cannot. It is to tight. The complaint is that they hardly can't remove the filter. And they are used to use nexiva.
 
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Brand NameNEXIVA 22GA 1.00IN CONNECTA W/ Q-SYTE
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
Manufacturer (Section G)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8516484
MDR Text Key145943355
Report Number9610847-2019-00299
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K161777
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/31/2021
Device Catalogue Number383662
Device Lot Number8177584
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/27/2018
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: 04/15/2019 Patient Sequence Number: 1
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