MAUDE Adverse Event Report: 9 FR INTRODUCER CENTRAL LINE KIT; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Device Problems Break (1069); Incorrect, Inadequate or Imprecise Result or Readings (1535); Component Missing (2306); Positioning Problem (3009); Physical Resistance/Sticking (4012)

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

Event Date 11/30/2022

Event Type  malfunction  

Event Description

Making postop rounds and nurse asked me to look at pa tracing as it did not look correct.It was obvious to me that the pa was not reading correctly.The swan was repositioned and while doing so the plastic sheath that covers the swan that keeps it sterile was damaged.To correct this, i would need to remove the swan and place it through a new intact sheath.While removing the swan, i did note a slight tension during swan removal.At this point, the md was contacted, and he came to assess the need for swan replacement.He noted the balloon was not on the end of the swan.I removed the introducer by his request.The sheath was examined and no evidence of the balloon in the sheath was noted.

• Brand Name: 9 FR INTRODUCER CENTRAL LINE KIT
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 16875571
• MDR Text Key: 314625805
• Report Number: 16875571
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2023,11/30/2022

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/05/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22630 DA
• Patient Sex: Male
• Patient Race: Black Or African American