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

Model Number 384232

Device Problems Fluid/Blood Leak (1250); Flushing Problem (1252); Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2020

Event Type  malfunction  

Manufacturer Narrative

The device is indicated as unavailable for evaluation.Without the device or any visual evidence to review, the complaint cannot be confirmed.If additional information is received in the future, a follow-up report will be provided.

Event Description

The patient maintained picc monolumen 1.9 fr in right lower limb (inserted on (b)(6) 2020 and was transferred from the neonatal center to ctin2 on (b)(6) presenting a catheter with blood in extension and resistant to salinization.On october /10 wet dressing was observed and when removing the identified microhole dressing.Pulled out picc and not forwarded tip to culture.There was no need to insert new venous access, it maintained only medications via enteral.Catheter data: argon brand (1.9 fr), silicone material, lot 11304081.

• 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
• Manufacturer Contact: gina liu ; 1445 flat creek rd, athens, tx 75751
• MDR Report Key: 11041663
• MDR Text Key: 223184145
• Report Number: 1625425-2020-00803
• 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
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 384232
• Device Catalogue Number: 384232
• Device Lot Number: 11304081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/25/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other