MAUDE Adverse Event Report: BECTON DICKINSON UNKNOW SALINE FLUSH; SALINE, VASCULAR ACCESS FLUSH

Catalog Number UNKNOWN

Device Problem Defective Component (2292)

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

Event Date 01/10/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Event Description

When preparing to use the prefilled irrigator, open the package and find that the irrigator push lever is loose.Stop using it immediately without causing any harm to the patient.

• Brand Name: UNKNOW SALINE FLUSH
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18629200
• MDR Text Key: 334409437
• Report Number: 2243072-2024-00104
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/25/2024

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1