MAUDE Adverse Event Report: BECTON DICKINSON NEXIVA 20 GA X 1 IN SINGLE PORT; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number 383516

Device Problem Defective Component (2292)

Patient Problems Exposure to Body Fluids (1745); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2023

Event Type  malfunction  

Event Description

In ct room, when withdrawing the needle core, the rubber stopper of the protective device broke and blood was spilled on the patient, no claim, need to replace the goods, but now it is not possible to determine how many need to be replaced, need a letter of response to the complaint, need a letter of acceptance of the complaint.

Manufacturer Narrative

(b)(4).: initial mdr submission.A follow up mdr will be submitted if a device evaluation and/or device history review is completed.Patient problem code: f26 ¿ no health consequences or impact.Device problem code: a0202 - defective component.

Manufacturer Narrative

(b)(4) follow up mdr (device history revew): no photos or physical samples that display the reported condition were available for investigation.A device history record review was completed by our quality engineer team for provided material number 383516 and lot number 3038465.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.Based on the available information, an exact cause for this incident could not be identified.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

Event Description

In ct room, when withdrawing the needle core, the rubber stopper of the protective device broke and blood was spilled on the patient, no claim, need to replace the goods, but now it is not possible to determine how many need to be replaced, need a letter of response to the complaint, need a letter of acceptance of the complaint.

• Brand Name: NEXIVA 20 GA X 1 IN SINGLE PORT
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: helen cox ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18275546
• MDR Text Key: 329844592
• Report Number: 1710034-2023-01393
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2023

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: Health Professional
• Device Catalogue Number: 383516
• Device Lot Number: 3038465
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 12/14/2023
• Supplement Dates FDA Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1