MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC S/L BASIC KIT 28GA (1.2F) X 25CM 1 LUMEN

Model Number 28 GA (1.2F) x 25cm

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Emotional Changes (1831); Erythema (1840); Extravasation (1842); Swelling/ Edema (4577)

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

The sample is indicated as 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 provided.

Event Description

At 1905 after shift report, baby started crying, writer entered bed space wearing proper ppe and baby would not settle with soother.Writer began to assess baby and noted that upper left chest and left bicep were red and swollen.Writer paused vancomycin that was running through the picc in the left ac.Baby stopped crying as soon as medication was not running through.With further assessment, left arm and shoulder area had a small palpable fluid-like mass and remained red and inflamed.Charge nurse called and fellow came to bedside to assess and immediately removed the picc line from the left ac.

• Brand Name: L-CATH PICC S/L BASIC KIT 28GA (1.2F) X 25CM 1 LUMEN
• Type of Device: L-CATH 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: 11724785
• MDR Text Key: 250390047
• Report Number: 1625425-2021-00913
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00886333209910
• UDI-Public: 00886333209910
• Combination Product (y/n): N
• PMA/PMN Number: K091670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 28 GA (1.2F) x 25cm
• Device Catalogue Number: 384516
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• 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