MAUDE Adverse Event Report: BECTON DICKINSON NEXIVA 24 GA X 9/16 IN SINGLE PORT; INTRAVASCULAR CATHETER

Catalog Number	383510
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	11/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
Material no.383510, batch no.9227579.It was reported that during use of the nexiva 24 ga x 9/16 in single port one of the nurses was stuck by the needle when trying to extract the exposed needle from the nexiva port which was stuck in the iv port.The following information was provided by the initial reporter: the injury resulted when the nurse was trying to remove the male end of the vacutainer holder from the nexiva female port.The luer slip end typically gets stuck in this port, and the vacutainer holder luers off, leaving the internal needle fully exposed to the nurse.Two nurses then tried to extract the exposed needle from this nexiva port, which was contaminated with patient blood, and one of the nurses was stuck by the needle.
Additional Manufacturer Narrative
H.1.Type of reportable events: serious injury.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.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.
Event or Problem Description
Material no.383510, batch no.9227579.It was reported that during use of the nexiva 24 ga x 9/16 in single port one of the nurses was stuck by the needle when trying to extract the exposed needle from the nexiva port which was stuck in the iv port.The following information was provided by the initial reporter: the injury resulted when the nurse was trying to remove the male end of the vacutainer holder from the nexiva female port.The luer slip end typically gets stuck in this port, and the vacutainer holder luers off, leaving the internal needle fully exposed to the nurse.Two nurses then tried to extract the exposed needle from this nexiva port, which was contaminated with patient blood, and one of the nurses was stuck by the needle.

• Brand Name: NEXIVA 24 GA X 9/16 IN SINGLE PORT
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9378026
• Report Number: 1710034-2019-01267
• Device Sequence Number: 2500089
• Product Code: FOZ
• UDI-Device Identifier: 30382903835103
• UDI-Public: 30382903835103
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 383510
• Device Lot Number: 9227579
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 01/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other