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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 INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383539
Device Problem Fail-Safe Design Failure (1222)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/31/2018
Event Type  malfunction  
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 when the nurse pulled the needle out of the placed plastic bd nexiva¿ closed iv catheter system, the "guard" covering the needle fell apart and the end of the needle was exposed. The nurse noticed the pin that holds the shield, and the needle fell out twice. No reports of serious injury or medical intervention noted.
 
Event Description
It was reported that when the nurse pulled the needle out of the placed plastic bd nexiva closed iv catheter system, the "guard" covering the needle fell apart and the end of the needle was exposed. The nurse noticed the pin that holds the shield, and the needle fell out twice. No reports of serious injury or medical intervention noted.
 
Manufacturer Narrative
Received a total of 3 catheter-adapter-ex. Sets, 3 needle covers, 2 q-syte units, 1 tip shield, 1 tip shield-grip assembly, 1 washer in a bag with handwritten notes, 1 cannula + a tip shield and a grip in a bag with a handwritten note and 3 empty-open packages from lot number 8087800 dhr review shows the lot was manufactured on nexiva line 1 from (b)(6) 2018 through (b)(6) 2018. All challenges were successful. Set-up and in process samples including (but not limited to) machine caused damaged were performed at various stages during the manufacturing process and all passed per specification. Visual/microscopic evaluation: observed the cannula returned for evaluation had a bump according to specification. Observed the tip shields were missing the washers. No further observations could be performed since the condition of the other cannulas is unknown. The failure experienced by the customer was confirmed, the grip-shield assemblies separated from the cannulas and the washers were missing. Bd was unable to reproduce the customer¿s experience in the laboratory environment. This incident is currently being investigated through a voluntary recall including field action: (b)(4). This is an issue with the safety feature of the device. Although occurrence is low and all reported incidents thus far have limited severity (contaminated needle stick injury with no known blood borne pathogen), there is the potential for higher severity end user effects. A capa project has been opened to address this incident. (b)(4) problem statement: the tip shield did not properly capture the tip of some nexiva 18ga needle between the v-clip and washer. Instead, due to the failure mode of bump out of specification (small or missing), the needle pulled through the washer and allowed the gray tip shield to disconnect from the needle assembly.
 
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Brand NameBD NEXIVA¿ CLOSED IV CATHETER SYSTEM
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key7621597
MDR Text Key112046631
Report Number1710034-2018-00372
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903835394
UDI-Public30382903835394
Combination Product (y/n)N
PMA/PMN Number
K111366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 09/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2018
Device Catalogue Number383539
Device Lot Number8087800
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/31/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/20/2018 Patient Sequence Number: 1
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