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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/12/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that 7 bd nexiva¿ closed iv catheter systems had blank packaging without labels or product information on them.The following information was provided by the initial reporter: "customer is receiving nexiva catheters with blank packaging.".

Manufacturer Narrative

H.6.Investigation: bd received seven sealed 22 gauge nexiva single port units from an unknown lot for evaluation.A review of the device history record could not be performed as the lot was unknown.Our quality engineer visually inspected the returned unit and observed that the packages were missing the print on the top label.Based off the visual inspection the engineer was able to verify the reported defect.It was determined that this was manufacturing defect that occurred during the packaging process.H3 other text : see h.10.

Event Description

It was reported that 7 bd nexiva¿ closed iv catheter systems had blank packaging without labels or product information on them.The following information was provided by the initial reporter: "customer is receiving nexiva catheters with blank packaging.".

• 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: 11467404
• MDR Text Key: 239395637
• Report Number: 1710034-2021-00184
• 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: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• 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: 03/04/2021
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1