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

Model Number 383532

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 10/08/2020

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.(b)(4).

Event Description

It was reported that foreign matter was found on the tip of the bd nexiva¿ closed iv catheter system before use.The following information was provided by the initial reporter: "just immediately after opening the package ready to insert the catheter, they found a big drop on the tip of the catheter.".

Event Description

It was reported that foreign matter was found on the tip of the bd nexiva¿ closed iv catheter system before use.The following information was provided by the initial reporter: "just immediately after opening the package ready to insert the catheter, they found a big drop on the tip of the catheter.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2020-11-17.H6: investigation summary: our quality engineer inspected the samples and photograph submitted for evaluation.Bd received one catheter adapter assembly in opened packaging and one fully assembled unit in unopened packaging.During the visual examination of the photo, it was observed that there was a clear piece of unknown material near the tip of the catheter.The opened unit was observed to have dirt and fibers on the catheter tip indicating that foreign matter or lubrication was present on the catheter tip.The clear substance was also found on the inner surface of the needle cover.The reported issue was confirmed.No foreign or visible defects were observed to the unopened unit.Spectral analysis was performed to identify the unknown substance.The material was identified to be a combination of saturated polyester and polyurethane rubber.Bd was unable to match the identified substances to materials used during manufacturing.Although the reported issue was confirmed, bd was unable to determine a definite root cause since the unit was received out of its original packaging and the substance did not match materials used during manufacturing.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• 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
• MDR Report Key: 10752390
• MDR Text Key: 214826905
• Report Number: 1710034-2020-00697
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835325
• UDI-Public: 30382903835325
• 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: 02/17/2021

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: 09/30/2022
• Device Model Number: 383532
• Device Catalogue Number: 383532
• Device Lot Number: 9279029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 02/14/2021
• Supplement Dates FDA Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1