MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Model Number 383536

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 12/02/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd nexiva¿ closed iv catheter system experienced difficult needle disengagement.The following information was provided by the initial reporter: we had a safety event reported.During this incident, the needle failed to come off from the bd nexiva closed iv catheter hub.Placed peripheral iv catheter in patient's arm.Retracted needle but was unable to remove the needle from the iv catheter hub.Two other nurses attempted removal but unsuccessful.Rn had to remove piv and place new another one.

Event Description

It was reported that the bd nexiva¿ closed iv catheter system experienced difficult needle disengagement.The following information was provided by the initial reporter: we had a safety event reported.During this incident, the needle failed to come off from the bd nexiva closed iv catheter hub.Placed peripheral iv catheter in patient's arm.Retracted needle but was unable to remove the needle from the iv catheter hub.Two other nurses attempted removal but unsuccessful.Rn had to remove piv and place new another one.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 09-jan-2023.H6: investigation summary: our quality engineer inspected the sample submitted for evaluation.Bd received one catheter assembly of a 20gx1.00in single port nexiva unit from lot number 1236482.The reported issue that the needle and tip shield failed to separate from the nexiva catheter hub was confirmed and the cause appeared to be manufacturing related.The needle was retracted but the tip shield would not decouple from the catheter adapter.Further investigation was performed by wiggling the wing adapter out of the shield.Upon separation, inspection of the tip shield revealed that plastic from the tip shield was catching the v-clip preventing release of the winged adapter.Upon separation of the two components damage to the inside of the tip shield where the winged adapter resides was found.Based on the location of the damage, the defect most likely originated during the manufacturing process while inserting the cannula into the grip and tip shield.A device history record review showed an in-process sampling where the cannula insertion was out of alignment during part of the production of this batch.The misalignment was addressed, and a random sampling was performed where the units passed and were then released.H3 other text : see h10.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• 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: 16030318
• MDR Text Key: 308258663
• Report Number: 1710034-2022-00843
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102520
• 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,Followup
• Report Date: 02/02/2023

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
• Device Operator: Other
• Device Expiration Date: 07/31/2024
• Device Model Number: 383536
• Device Catalogue Number: 383536
• Device Lot Number: 1236482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 02/02/2023
• Supplement Dates FDA Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2021
• 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