MAUDE Adverse Event Report: INTERNATIONAL LLC (SUBSIDIARY OF TELEFLEX INCORPORATED) MAC TWO LUMEN CENTRAL VENOUS ACCESS KIT CATH GARD; INTRODUCER, CATHETER

Lot Number CDC-11242-1A

Device Problems Suction Problem (2170); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 11/23/2021

Event Type  malfunction  

Event Description

Central line placed in surgery, when staff went to draw inability to aspirate, line changed out and it was noted that the initial line did not have a hole in the side- defective two lumen central venous catheter.Fda safety report id # (b)(4).

• Brand Name: MAC TWO LUMEN CENTRAL VENOUS ACCESS KIT CATH GARD
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): INTERNATIONAL LLC (SUBSIDIARY OF TELEFLEX INCORPORATED)
• MDR Report Key: 12883092
• MDR Text Key: 281507637
• Report Number: MW5105619
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: CDC-11242-1A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Race: White