MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. L-CATH PICC 26G (1.9F) 0.60MM X 30CM

Catalog Number 384539

Device Problem Insufficient Information (3190)

Patient Problems Respiratory Distress (2045); Swelling (2091)

Event Date 05/31/2013

Event Type  Injury  

Manufacturer Narrative

The device sample was not available for evaluation.A lot number was not provided, so a review of device history records could not be conducted.Based on the available information, the root cause cannot be established; therefore, no corrective actions will be taken.L-cath catheters are 100% inspected at various times during manufacturing, including visual inspection as well as leak and flow testing.Catheters from each lot also undergo pull testing to ensure the ability of the catheter to endure normal use.Additionally, the instructions for use include guidance that can help to mitigate the occurrence of damage to the catheter.

Event Description

Picc was inserted on (b)(6) 2013.The child became symptomatic (b)(6) 2013.Symptoms include swelling at insertion site at right arm, swelling in chest, and respiratory distress.As of 2016, the patient has limited mobility of the right arm, hands, and fingers.The patient was born 2 months premature on (b)(6) 2013.

• Brand Name: L-CATH PICC 26G (1.9F) 0.60MM X 30CM
• Type of Device: PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek road; athens TX 75751
• Manufacturer (Section G): ARGON MEDICAL DEVICES, INC.
• Manufacturer Contact: gail smith ; 1445 flat creek road; athens, TX 75751 ; 2144368995
• MDR Report Key: 5957886
• MDR Text Key: 55001629
• Report Number: 1625425-2016-00053
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 384539
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/22/2016
• Initial Date FDA Received: 09/16/2016
• 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): Disability
• Patient Age: 52 DA