MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM

Model Number 384232

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem Chills (2191)

Event Date 07/14/2020

Event Type  malfunction  

Manufacturer Narrative

The device is indicated as available for evaluation.As of the date of this report, the sample has not yet been returned.A follow-up report will be provided once the sample has been received and reviewed.

Event Description

Per (b)(6), nurse assessed the patient and noticed the dressing was wet; picc snapped.Picc removed, and new picc placed.Picc was placed on (b)(6) 2020.Date of event (b)(6) 2020.

Event Description

Follow up.

• Brand Name: FIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM
• Type of Device: FIRST PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 10352894
• MDR Text Key: 202362746
• Report Number: 1625425-2020-00451
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00886333209750
• UDI-Public: 00886333209750
• Combination Product (y/n): N
• PMA/PMN Number: K972262
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/31/2020

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 Expiration Date: 09/19/2022
• Device Model Number: 384232
• Device Catalogue Number: 384232
• Device Lot Number: 11276377
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1