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

Model Number 383531

Device Problem Defective Component (2292)

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

Event Date 07/08/2022

Event Type  malfunction  

Manufacturer Narrative

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 disfigured/sunken septum of q-syte.The following information was provided by the initial reporter: when checking the product before use after unpacking the sterilized package, the hcp confirmed an abnormal finding on the septum of q-syte.

Event Description

It was reported that the bd nexiva¿ closed iv catheter system experienced disfigured/sunken septum of q-syte.The following information was provided by the initial reporter: when checking the product before use after unpacking the sterilized package, the hcp confirmed an abnormal finding on the septum of q-syte.

Manufacturer Narrative

H6: investigation summary: our quality engineer inspected the sample and photographs provided for evaluation.Bd received three photos and one nexiva closed iv catheter system with a bd q-syte in an opened package.Upon visual inspection of the component, damage to the q-syte was found.Further microscopic evaluation was performed for better image quality and the top disk was found to be partially pushed in.Per the report, the defect was found before use and because adhesive could not be observed on the top body nor signs of usage, it is unlikely that the defect occurred in the clinician environment.During manufacturing, low bond strength (or insufficient adhesive) may result in the septum being pushed in.Operator-controlled checks for bond strength and septum damage are performed to mitigate the risk from this type of defect.Additionally, preventative maintenance (pm) is performed to ensure tooling is replaced per the quality plan and the equipment is functioning properly.Pm records were verified to be up to date during the production of this lot.A device history record review showed no non-conformances associated with this issue during the production of this batch.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: 15180412
• MDR Text Key: 302578404
• Report Number: 1710034-2022-00422
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835318
• UDI-Public: 30382903835318
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 383531
• Device Catalogue Number: 383531
• Device Lot Number: 1154429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2021
• 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