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

Model Number 383539

Device Problem Material Deformation (2976)

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

Event Date 02/07/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported while using bd nexiva¿ closed peripheral iv catheter system the product was defective yet operable.The following information was provided by the initial reporter: material no:383539   it was reported by the consumer defective nexiva.

Manufacturer Narrative

H6: investigation summary bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.A device history review could not be completed as no batch number was provided.

Event Description

It was reported while using bd nexiva¿ closed peripheral iv catheter system the product was defective yet operable.The following information was provided by the initial reporter: material no:383539.  it was reported by the consumer defective nexiva.

Manufacturer Narrative

The following fields were updated due to additional information: b5: describe event or problem: it was reported while using bd nexiva¿ closed peripheral iv catheter system the product was defective yet operable.There were three occurences.The following information was provided by the initial reporter: material no:383539   it was reported by the consumer defective nexiva.

Event Description

It was reported while using bd nexiva¿ closed peripheral iv catheter system the product was defective yet operable.There were three occurences.The following information was provided by the initial reporter: material no:383539.  it was reported by the consumer defective nexiva.

• Brand Name: BD NEXIVA¿ CLOSED PERIPHERAL 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: 13552325
• MDR Text Key: 286496940
• Report Number: 1710034-2022-00083
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835394
• UDI-Public: 30382903835394
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183399
• 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,Followup
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 383539
• Device Catalogue Number: 383539
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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