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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. 20 G X 1 IN. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 20 G X 1 IN. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383556
Device Problems Fail-Safe Design Failure (1222); Device Operates Differently Than Expected (2913)
Patient Problem Needle Stick/Puncture (2462)
Event Date 09/26/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation: according the customer information the sample received was analyzed visual and functionally and it did not show any issue at moment of attempting remove the cannula from the tip shield component, once that the cannula was removed from the back of the septum this keep into the tip shield without move out of this, this sample show a good safety shield activation. Please see attached photos in the additional information section. Complaint trending review for this lot# 7068505 related to this issue reveals 1st complaint for this failure mode, previously 7 complains per safety shield activation has been reveal before, all of them were confirmed as a manufacturing issue. During the dhr review was not detected issues related to safety shield activation, the lot 7068505 was manufactured on march 2017 and no qn related to this lot was documented, no issues related to our q. A tech control plan that could help this issue to occur was detected. Manufacturing review: as part of our manufacturing process a linear torque arm was installed in order to avoid cannula hits, this station was updated also as an ergonomic improve help us to mitigate this failure mode. This quality issue has previously reviewed but some of them have been classified as not confirmed to the manufacturing process. Base on the parent evaluation s1 and low occurrence concludes no further action is required at this time. We will continue to monitor for trends. Bd was unable to duplicate or confirm the customer¿s indicated failure mode because the defect was not evident in the visual and functional inspection of the returned sample. We could not confirm a specific root cause for this issue since the actual sample received didn¿t show any issue related to the incident reported.
 
Manufacturer Narrative
The date of event was provided after mdr was submitted. Date of event updated to (b)(6) 2017.
 
Manufacturer Narrative
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 the safety mechanism on a 20 g x 1 in. Bd nexiva¿ closed iv catheter system failed to function properly, leaving the needle exposed. This resulted in a clean needle stick and there was no report of medical interventions.
 
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Brand Name20 G X 1 IN. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
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
8015652845
MDR Report Key6984144
MDR Text Key248229475
Report Number9610847-2017-00124
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K161777
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 01/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/29/2020
Device Catalogue Number383556
Device Lot Number7068505
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 Received10/02/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/27/2017
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: 10/27/2017 Patient Sequence Number: 1
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