MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. PERIPHERALLY INSERTED CENTRAL CATHETER LINE; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number MEDICAL DEVICES INC.

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

Event Date 04/15/2024

Event Type  malfunction  

Event Description

Single lumen picc(peripherally inserted central catheter) line broken off from the base of catheter.

• Brand Name: PERIPHERALLY INSERTED CENTRAL CATHETER LINE
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.
• MDR Report Key: 19212837
• MDR Text Key: 341525002
• Report Number: MW5154432
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 04/25/2024

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
• Device Operator: Health Professional
• Device Model Number: MEDICAL DEVICES INC.
• Device Lot Number: 11492204
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/29/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 1 MO
• Patient Sex: Female
• Patient Ethnicity: Hispanic