MAUDE Adverse Event Report: MEDLINE INDUSTRIES - MUNDELEIN CENTRAL LINE DESSING KIT - BDCORAM2; CENTRAL VENOUS CATHETER DRESSING CHANGE KIT

Device Problem Material Puncture/Hole (1504)

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

Event Type  Injury  

Event Description

Patients iv line was replaced.Patient discovered hole in line this morning, patient contacted md and was instructed to go to emergency room on (b)(6) 2020 to have line changed.New line is a single lumen hickman.No other information available.The length of emergency room visit is unknown.No additional adverse events or side effects were mentioned due to the issue.No further dates, details or information were provided.Reported to (b)(6) by patient/caregiver.

• Brand Name: CENTRAL LINE DESSING KIT - BDCORAM2
• Type of Device: CENTRAL VENOUS CATHETER DRESSING CHANGE KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES - MUNDELEIN
• MDR Report Key: 10816453
• MDR Text Key: 216188266
• Report Number: MW5097758
• Device Sequence Number: 1
• Product Code: PEZ
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/09/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other