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

Catalog Number UNKNOWN

Device Problem Disconnection (1171)

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

Event Date 12/30/2023

Event Type  malfunction  

Manufacturer Narrative

Pr (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.H3 other text : see h10 manufacture narrative.

Event Description

Comply with the doctor's instructions for dehydration to reduce cranial pressure, anti-inflammatory, gastric protection, awakening and other supportive symptomatic treatment.After the infusion, a pre-filled catheter flusher was given to seal the tube, and the end of the catheter fell off from the piston during the pulling process, which was immediately explained to the patient's family and replaced with a new catheter flusher for continued use.

• 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 (Section G): BD MDS DCHU; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18605612
• MDR Text Key: 334146134
• Report Number: 2243072-2024-00075
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065470
• UDI-Public: (01)30382903065470
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K003553
• 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: 01/10/2024

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: 01/08/2024
• Initial Date FDA Received: 01/30/2024
• 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