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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 383532
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 11/17/2017
Event Type  Injury  
Manufacturer Narrative
Bd received samples from the customer facility for investigation. A visual/microscopic examination revealed that the edges of the remaining catheter tubing were smooth, with the exception of a small portion which exhibited roughness and jaggedness. The customer's experience was confirmed by the returned unit. The reported defect was not created during the manufacturing process. Had this damage occurred to the device prior to insertion into the patient's vasculature, the device would not have been successfully inserted as reported in the customer's verbatim description. Furthermore, the device would not have performed under power injection, which was reported as successful and without incident in the verbatim description. Bd was unable to determine the specific lot number associated with this complaint. Therefore, a review of the device history record could not be conducted. The reported defect did not occur as a result of the manufacturing process or design of the product.
 
Manufacturer Narrative
Initial mdr report stated "date received by manufacturer" was 11/28/2017 instead of 11/20/2018.
 
Manufacturer Narrative
A sample is available for evaluation. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that when a bd nexiva¿ closed iv catheter system was removed from the patients arm, the plastic cannula got internally dislodged and remained in the patient¿s vein. The patient was seen in the emergency room where an ultrasound was ordered to confirm. The following day the patient was taken to the operating room for 2nd ultrasound but upon further exploration nothing was found. Patient was then placed on outpatient observation for additional imaging. A ct of the chest without contrast was obtained with the following results: "thin linear density within the sub segmental lateral basal segment right lower lobe pulmonary artery¿. The patient has been ordered to follow up in 3 months.
 
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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
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
8015652845
MDR Report Key7137167
MDR Text Key110476480
Report Number1710034-2017-00472
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161777
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 02/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other Health Care Professional
Device Catalogue Number383532
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2017
Was Device Evaluated by Manufacturer? Yes
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: 12/21/2017 Patient Sequence Number: 1
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