MAUDE Adverse Event Report: DYNAREX CORP. DYNAREX PAPER SURGICAL TAPE; TAPE AND BANDAGE, ADHESIVE

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

A registered nurse reported to fresenius medical care customer service that hd patient was using dynarex new paper tape provided by(b)(6) pharmacy when her arterial needle became dislodged due to the tape not sticking to her skin.This caused her to have needle dislodgement resulting in air in the lines and loss of cartridge with blood.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DYNAREX PAPER SURGICAL TAPE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): DYNAREX CORP.
• MDR Report Key: 18574389
• MDR Text Key: 333722397
• Report Number: MW5150687
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/22/2024

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/23/2024
• Patient Sequence Number: 1