MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. NEXIVA 20 GA X 1.75IN SP WITH MAXZERO; INTRAVASCULAR CATHETER

Catalog Number	383558
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that nexiva 20 ga x 1.75in sp with maxzero safety mechanism was difficult to disengage.The following information was provided by the initial reporter: it was reported by the health professional that the plastic on the hub was misshapen which made the needle difficult to remove from the device.Per email: while placing a bd nexiva 20 gauge 1.75" iv i was unable to remove the needle.Prior to starting the iv i "broke the seal" on the iv which is the standard practice.Once the iv was placed in the patient i pulled back on the needle and heard an audible click when the needle retracted into its safety node.At this point, the needle normally just falls off and is easy to remove safely.Instead, the needle remained stuck on the end of the butterfly section of the iv.Finally, after gentle and careful manipulation i was able to remove the needle safely.Upon inspection i noted that the iv catheter area where the needle attaches to the catheter had a small defect in the plastic (the plastic was misshapen).This defect i assume was what was hindering the removal of the needle.
Event or Problem Description
It was reported that nexiva 20 ga x 1.75in sp with maxzero safety mechanism was difficult to disengage.The following information was provided by the initial reporter: it was reported by the health professional that the plastic on the hub was misshapen which made the needle difficult to remove from the device.Per email: while placing a bd nexiva 20 gauge 1.75" iv i was unable to remove the needle.Prior to starting the iv i "broke the seal" on the iv which is the standard practice.Once the iv was placed in the patient i pulled back on the needle and heard an audible click when the needle retracted into its safety node.At this point, the needle normally just falls off and is easy to remove safely.Instead, the needle remained stuck on the end of the butterfly section of the iv.Finally, after gentle and careful manipulation i was able to remove the needle safely.Upon inspection i noted that the iv catheter area where the needle attaches to the catheter had a small defect in the plastic (the plastic was misshapen).This defect i assume was what was hindering the removal of the needle.
Additional Manufacturer Narrative
H6: investigation summary: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• Brand Name: NEXIVA 20 GA X 1.75IN SP WITH MAXZERO
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 11917456
• Report Number: 1710034-2021-00452
• Device Sequence Number: 804889
• Product Code: FOZ
• UDI-Device Identifier: 00382903835584
• UDI-Public: 00382903835584
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 383558
• Device Lot Number: 0275004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1