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

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

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.

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.

• 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: 7137167
• MDR Text Key: 95449460
• Report Number: 1710034-2017-00472
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835325
• UDI-Public: 30382903835325
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161777
• Number of Events Reported: 1
• 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 Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 383532
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention