MAUDE Adverse Event Report: HICKMAN CATHETER; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Device Problems Increase in Pressure (1491); Obstruction of Flow (2423)

Patient Problems Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559)

Event Date 11/29/2021

Event Type  Injury  

Event Description

Spontaneous call from patient for (b)(6) 2021 high pressure on both pumps, patient went to the er and a fibrin clot was removed from hickman line.Md informed.No further information provided.Did the reported product fault occur while in use with the patient? yes; did the product issue cause or contribute to patient or clinical injury? yes; if yes, was any medical intervention provided? yes; is the actual device available for investigation? unknown; did we [mfr] replace device? unknown; did the patient have a backup device they were able to switch to? unknown.Patient went to er is the infusion life-sustaining? yes; what is the outcome of the event? unknown.Reported to (b)(6) by pt/caregiver.

• Brand Name: HICKMAN CATHETER
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• MDR Report Key: 12916983
• MDR Text Key: 281689954
• Report Number: MW5105732
• Device Sequence Number: 3
• Product Code: LJT
• 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: 11/29/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2021
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Sex: Male