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

Model Number ARGON 1.9F

Device Problem Gas/Air Leak (2946)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/09/2019

Event Type  malfunction  

Event Description

Intravenous team (ivt) consulted for assessment of picc line.76do with gastroschisis; picc line for nutrition, meds, iv access; staff nurses concerned with line "bubbling/with flushes" unclear how long it had been happening or noted; line assessed by ivt, recommendations to remove and not use due to concern for malfunction of line; new peripheral iv placed by iv team.

• Brand Name: PICC LINE
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek rd.; athens TX 75751
• MDR Report Key: 9150892
• MDR Text Key: 161168601
• Report Number: 9150892
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARGON 1.9F
• Device Lot Number: 11244512
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1