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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 INTERVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383532
Device Problem Leak/Splash (1354)
Patient Problem Chemical Exposure (2570)
Event Date 07/09/2019
Event Type  malfunction  
Manufacturer Narrative
Device expiration date: unknown. Device manufacture date: unknown. Investigation summary: bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided. This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences. The complaint was deemed as mdr reportable therefore a submission will be performed. Shall a sample or lot number become available, the complaint will be re-opened and an investigation will take place. This complaint will be closed at this time.
 
Event Description
It was reported that leakage occurred during use with a bd nexiva¿ closed iv catheter system. The following information was provided by the initial reporter, "customer called and stated that while power injecting , the contrast came out of the dual port and splashed on the face of the radiation technician. Item no: 383532, lot no. Unknown, customer stated she can provided the information when she gets it from the nurse. The technician washed their face after getting sprayed, not first aid was administered. Customer does not have sample at the moment, but would have to ask her nurse if sample is available. Cn stated this type of incident has occurred in one of their locations long ago, customer requests call back to know if the catheter is supposed to be used for power injections. ".
 
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Brand NameBD NEXIVA¿ CLOSED IV CATHETER SYSTEM
Type of DeviceINTERVASCULAR 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 Key8848882
MDR Text Key153860438
Report Number1710034-2019-00827
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 other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number383532
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 Received07/09/2019
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: 07/31/2019 Patient Sequence Number: 1
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