MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD NEXIVA CATHETER; INTRAVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

Patient Problem Infiltration into Tissue (1931)

Event Date 09/27/2022

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.The customer's address is unknown:  (b)(6) has been used as a default.  investigation summary: as no physical sample, valid part number or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the unspecified bd nexiva catheter experienced difficult needle disengagement, catheter splitting, and a broken needle.The removal of the broken device piece required medical intervention, with the patient being administered "lido" and the needle and catheter being cut out of the patient's tissue.The following information was provided by the initial reporter: ed rn unable to thread nexiva.Met resistance and made adjustments to reposition needle.Placement was unsuccessful so rn attempted to remove nexiva & needle but was unable to remove.It was stuck in the tissue.Provider administered lido and cut out the needle and catheter.Catheter was sheared.

• Brand Name: UNSPECIFIED BD NEXIVA CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15663932
• MDR Text Key: 302329542
• Report Number: 2243072-2022-01819
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention