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

Model Number 383512

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that bd nexiva¿ closed iv catheter system was missing labels on 4 occasions before use.The following information was provided by the initial reporter: material no.: 383512 batch no.: unknown.It was reported the catheters are unlabeled.

Event Description

It was reported that bd nexiva¿ closed iv catheter system was missing labels on 4 occasions before use.The following information was provided by the initial reporter: material no.: 383512 batch no.: unknown it was reported the catheters are unlabeled.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 7/22/2020.H.6.Investigation: bd received four unopened 22 gauge nexiva single port iv catheter units from an unknown lot.A review of the device history record could not be performed as the reported lot was unknown.Our quality engineer visually inspected the returned units and observed that the top web of the packaging did not have any print or identifiers for the units inside.The bottom web was then inspected and found to be missing identifiers as well.Based off the visual inspection the engineer was able to verify the reported defect.It was determined that this was most likely an operator error that occurred when splicing the top web.The manufacturing facility has been notified of this incident and the findings.A notification was issued to all packaging operators to raise awareness of this issue and prevent recurrence.

• 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: 10282841
• MDR Text Key: 199711386
• Report Number: 1710034-2020-00457
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835127
• UDI-Public: 30382903835127
• Combination Product (y/n): N
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 383512
• Device Catalogue Number: 383512
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Date Manufacturer Received: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other