MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC S/L 26GA (1.9F) X 50CM 1 LUMEN

Model Number 384221

Device Problems Material Fragmentation (1261); Material Rupture (1546)

Patient Problem Insufficient Information (4580)

Event Date 06/08/2021

Event Type  malfunction  

Manufacturer Narrative

No sample or images are available for evaluation.Without such evidence to review, the complaint cannot be confirmed.If additional information is provided in the future, a follow-up report will be submitted.

Event Description

Central catheter was inserted in a newborn on (b)(6) 2021, during the course of the same day the device was replaced.At the occasion there was rupture of the device, with displacement of an 8cm fragment to the cardiac area.The removal of the fragment occurred on (b)(6) 2021 by the vascular surgery team.Soon after the procedure, the patient had a clinical worsening of the condition, evolving with tonic-clonic movements.Adverse event: tonic clonic seizures.".

• Brand Name: FIRST PICC S/L 26GA (1.9F) X 50CM 1 LUMEN
• Type of Device: FIRST PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• MDR Report Key: 12425509
• MDR Text Key: 271263710
• Report Number: 0001625425-2021-01075
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00886333209743
• UDI-Public: 00886333209743
• 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: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 384221
• Device Catalogue Number: 384221
• Device Lot Number: 11275539
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/18/2021
• 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
• Patient Outcome(s): Other