MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC S/L 18GA (4F) 1.35MM X 65CM

Model Number 384157

Device Problem Material Perforation (2205)

Patient Problem Insufficient Information (4580)

Event Date 07/21/2021

Event Type  malfunction  

Manufacturer Narrative

The sample is unavailable for evaluation.Without such evidence to review, the complaint cannot be confirmed.If additional information is received in the future, a follow-up report will be submitted.

Event Description

According to the nursing report: "picc was passed, and after tracing the guide wire and salinizing the catheter, it was observed that it was perforated near the oval disc".

• Brand Name: FIRST PICC S/L 18GA (4F) 1.35MM X 65CM
• Type of Device: FIRST PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• MDR Report Key: 12319702
• MDR Text Key: 268024068
• Report Number: 0001625425-2021-01062
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00886333209682
• UDI-Public: 00886333209682
• Combination Product (y/n): N
• PMA/PMN Number: K972262
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 384157
• Device Catalogue Number: 384157
• Device Lot Number: 11317182
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1