MAUDE Adverse Event Report: CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Lot Number 3152379

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 05/09/2023

Event Type  Injury  

Event Description

Pt initials:(b)(6).Date of awareness: 05/15/2023; provider rems id:(b)(6).Reporter: pharmacist; causality: unrelated.Pt visited emergency room for catheter complication, unrelated to ambrisentan.Adverse event report from (b)(6) pharmacy, for pt n/a.(b)(4).

• Brand Name: CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• MDR Report Key: 16953884
• MDR Text Key: 315562652
• Report Number: MW5117653
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 05/15/2023

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
• Device Lot Number: 3152379
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/17/2023
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Sex: Male