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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 20 G X 1.00 IN. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH DUAL PORT

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 20 G X 1.00 IN. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH DUAL PORT Back to Search Results
Catalog Number 383536
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Apnea (1720); Vomiting (2144); Loss of consciousness (2418)
Event Date 01/09/2016
Event Type  Injury  
Manufacturer Narrative
(b)(6). Device evaluation: a supplemental report will be filed upon completion of the investigation.
 
Event Description
It was reported that the patient went to surgery for a laparoscopic appendectomy on (b)(6) 2016 at approximately 1600. A ward cannula with two ports was used for rapid sequences induction using alfentanil, thiopentone and suxamethonium. After suxamethonium was given, the cannula was flushed with 0. 9% saline. A second cannula inserted and was used to give atracurium and other medications used for the rest of the case. At the end of surgery, the second cannula was flushed after it was used for medications. The patient had vomited during the procedure so the patient was suctioned and then extubated when fully awake. The patient recovered and returned to the ward with both cannulas in situ, which is against department protocol due to human error. However, after the complicated extubation, the cannula removal was forgotten. Later that night, the first cannula was flushed prior to use by the nursing staff. Possible residual muscle relaxant was flushed into the patient, causing an episode of awareness and then apnea, as described by the patient and surgical team. He required airway assistance by the met team before recovering full airway self management. The facility reported that "it seems probable that on flushing one port, the anaesthetic drug migrated around the y-connector and was not flushed successfully into the patient at the end of the anaesthetic. Bench testing of the cannula seems to confirm this. " the event was discussed with the patient and counseling was to be arranged for him.
 
Manufacturer Narrative
Adverse type: based off device evaluation, "adverse type" has been changed to reflect adverse event only. Device evaluation: result - a sample is not available for investigation. A review of the device history record cannot be completed as the lot number was not provided for this incident. Observations of bd drawings for the nexiva luer adapter dual port and the saf-t intima y-adapter show that space between the region where the male luer fitting is inserted into the y-luer adapter and the main flow path is necessary to accommodate connection to multiple luer access ports. Conclusions - bd was unable to confirm or reproduce the customer complaint as a sample was not returned for evaluation and testing. However, any luer adapter with a y-shaped, dual luer access port will have a volume requiring flush from both luer access ports to ensure complete flush. The relationship of the device to the reported incident is the device design. The root cause of this problem is linked to all iso compliant y-adapters there is no corrective action that can take place to reduce the risk. Customer complaint trends are evaluated on a monthly basis. If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.
 
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Brand Name20 G X 1.00 IN. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH DUAL PORT
Type of DeviceCLOSED IV CATHETER SYSTEM
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 Key5464591
MDR Text Key39204900
Report Number1710034-2016-00014
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K102520
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number383536
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/02/2016
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

Patient Treatment Data
Date Received: 02/26/2016 Patient Sequence Number: 1
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