MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC SILICONE SINGLE LUMEN 26GA (1.9F) X 50 CM

Model Number 384221

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Extravasation (1842)

Event Date 08/05/2020

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 product, peripheral inserted central venous catheter, during infusion, presented crack or break leakage in the weld between the central connection and the catheter.Adverse event : extravasation the infusion site.

• Brand Name: FIRST PICC SILICONE SINGLE LUMEN 26GA (1.9F) X 50 CM
• 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: 10513425
• MDR Text Key: 207564979
• Report Number: 1625425-2020-00513
• 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
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• 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: 11275540
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/18/2019
• 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