MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 24 GA 0.75 IN; INTRAVASCULAR CATHETER

Model Number 383511

Device Problem Material Perforation (2205)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/04/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.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 was reported while using bd nexiva¿ closed iv catheter system ¿ single port 24 ga 0.75 in the needle pierced the catheter.There was no report of patient impact.The following information was provided by the initial reporter: it was reported needle through catheter.

Manufacturer Narrative

Investigation summary our quality engineer inspected the photograph submitted for evaluation.Bd received one photograph which displayed the needle piercing through the catheter mid length confirming the reported defect.Traces of blood are present throughout the catheter length.As the device has been used it is very unlikely that the defect originated during manufacturing as the end user would receive the needle pierced through the catheter wall in a y shape.If an attempt was made to insert the catheter with y shape, the needle would not advance into the patient¿s skin past the spear and cause excessive pain.Also, if the catheter was speared before insertion at the length shown in the pictures attached, blood will not be able to reach the tip of the catheter unlike what is observed in the provided pictures.Based on the evidence gathered, the device was most likely pierced when performing venipuncture.A device history record review showed no non-conformance's associated with this issue during the production of this batch.

Event Description

It was reported while using bd nexiva¿ closed iv catheter system ¿ single port 24 ga 0.75 in the needle pierced the catheter.There was no report of patient impact.The following information was provided by the initial reporter: it was reported needle through catheter.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 24 GA 0.75 IN
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14218269
• MDR Text Key: 290446430
• Report Number: 1710034-2022-00214
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835110
• UDI-Public: 30382903835110
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 383511
• Device Catalogue Number: 383511
• Device Lot Number: 1224641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2021
• 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