MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. FIRST PICC; PICC LINE

Catalog Number 384232

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 02/22/2017

Event Type  malfunction  

Event Description

Picc line broke off approx 2 inches below the access port.

• Brand Name: FIRST PICC
• Type of Device: PICC LINE
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC. ; athens TX 75751
• MDR Report Key: 6367702
• MDR Text Key: 68845009
• Report Number: MW5068196
• Device Sequence Number: 1
• Product Code: FOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2017
• Device Catalogue Number: 384232
• Device Lot Number: 1114499Z
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 7 DA
• Patient Weight: 1