MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA SINGLE PORT 20GA 1.00IN (1.1 MM X 25 MM); INTRAVASCULAR CATHETER

Catalog Number 383516

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/13/2019

Event Type  malfunction  

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 Description

It has been reported that one bd nexiva single port 20ga 1.00in (1.1 mm x 25 mm) has been found with the needle piercing through the catheter during use.The following has been provided by the initial reporter: when the cannula was being inserted into the vessel, the needle has pierced through the plastic cannula.The cannula was being inserted by the nurse into the vessel, and on confirmation of blood, thus entry into vessel, the cannula was unable to be advanced into the vessel.At this point the cannula was withdrawn, and it was observed that the needle had pierced the plastic cannula.

Manufacturer Narrative

H.6.Investigation: our quality engineer inspected the photographs provided.Bd received three photographs which displayed a nexiva 20ga unit being held revealing the needle had pierced through the catheter tubing.There was a needle cover on top of an empty package and under the package was a 20ga straight luer adapter with an attached vent plug.There were body fluids in the catheter tubing.The last photograph displayed a nexiva package label.Through the evaluation of the photographs the reported issue of the needle spearing through the catheter was confirmed.Since bodily fluids were observed within the unit indicated that the needle and catheter were correctly assembled at the time of use.If the unit were in the condition as seen in the photographs, the catheter would not have been able to penetrate the skin.The defect observed is not manufacturing related.A device history record review showed no non-conformances associated with this issue during the production of this batch.

Event Description

It has been reported that one bd nexiva single port 20ga 1.00in (1.1 mm x 25 mm) has been found with the needle piercing through the catheter during use.The following has been provided by the initial reporter: when the cannula was being inserted into the vessel, the needle has pierced through the plastic cannula the cannula was being inserted by the nurse into the vessel, and on confirmation of blood, thus entry into vessel, the cannula was unable to be advanced into the vessel.At this point the cannula was withdrawn, and it was observed that the needle had pierced the plastic cannula.

• Brand Name: BD NEXIVA SINGLE PORT 20GA 1.00IN (1.1 MM X 25 MM)
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 9396099
• MDR Text Key: 178189467
• Report Number: 1710034-2019-01276
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835165
• UDI-Public: 30382903835165
• Combination Product (y/n): N
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 383516
• Device Lot Number: 9179020
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other