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

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.

• Brand Name: 20 G X 1.00 IN. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH DUAL PORT
• Type of Device: CLOSED 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 Key: 5464591
• MDR Text Key: 39204900
• Report Number: 1710034-2016-00014
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K102520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 383536
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2016
• Initial Date FDA Received: 02/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/01/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention