MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383532

Device Problems Break (1069); Occlusion Within Device (1423); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/27/2016

Event Type  Injury  

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 a bd nexiva closed iv catheter system had been in place in a patient's arm for four days.The hospital staff had observed the patient picking at the iv site and on day four found that the catheter was broken.An ultrasound was performed and the broken piece of catheter was thought to have been viewed so a vein cut down was done to retrieve it.It was found with venous exploration that what was thought to be the broken iv catheter was actually a blood clot.The patient then received another ultrasound, vein mapping, and a full body ct scan to search for the broken iv catheter.The catheter was not found within or outside of the patient.No additional medical interventions were provided.

Manufacturer Narrative

Results: one used nexiva 22ga catheter adapter assembly with extension tubing set with attached dual port adapter was returned for evaluation.A visual inspection revealed a q-syte attached to each of the ports with attached green caps.No needle set was returned.A microscopic inspection revealed that approximately 1/4 inch of catheter tubing extended from the nose of the catheter adapter.The edges of the cut are clean, sharp and slightly jagged.There was no outward puncture that may indicate a swage pin.Using a lab supplied representative nexiva product performed a simulation.The lab supplied unit was cut with scissors and compared to the complaint sample.The lab supplied unit revealed similar characteristics has the returned complaint sample.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6011575.Conclusion: an absolute root cause for this incident cannot be determined.Additionally, our quality engineer notes that given the catheter did not leak or separate during insertion, this provides evidence that the damage is not due to a manufacturing defect.The investigation results were also reviewed by a zone engineer and another engineer and they indicated that the damage observed was not likely caused in our manufacturing processes.An r&d engineer also stated that he believes that the physical evidence indicates that the catheter was accidentally cut during the undressing of the catheter from the patient.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR 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 Key: 5653000
• MDR Text Key: 45128343
• Report Number: 1710034-2016-00025
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 383532
• Device Lot Number: 6011575
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/28/2016
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention