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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. 1ST PICC SIL S/L PED 2.8F X 50CM CATH

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ARGON MEDICAL DEVICES, INC. 1ST PICC SIL S/L PED 2.8F X 50CM CATH Back to Search Results
Catalog Number 384101
Device Problems Material Fragmentation (1261); Difficult to Remove (1528); No Flow (2991)
Patient Problems Cardiopulmonary Arrest (1765); Death (1802)
Event Date 11/26/2015
Event Type  malfunction  
Manufacturer Narrative
The complaint lot was manufactured by bd medical and products were subsequently acquired by argon medical devices. Bd medical provided a review of the manufacturing documents related to this lot. There were no deviations or abnormalities which would affect the quality of the product. One catheter was returned for evaluation. The tip of the catheter was reviewed under magnification, and did not exhibit a square or smoothly cut end. The length of the catheter tubing was visually inspected and no concerns were noted. Additionally, water was flushed through the catheter in an attempt to determine if the lumen of the catheter was fully open. No resistance to flushing was noted whatsoever. As the appearance of the catheter was normal, and as the catheter was found to have no occlusion, it is most likely that the lack of blood return was an indication that the catheter was malpositioned (for example, the tip may have been against a wall of the vessel or outside of the vasculature). The ifu gives detail instructions to follow when resistance to catheter removal is encountered to avoid damage to the catheter. Additionally, it should be noted that the catheter was found attached to a 3 ml syringe. According to the instructions for use, "use a 10 ml syringe design to flush the catheter. Do not use force to flush the catheter as a 10 ml syringe design has the potential to generate high pressure (greater than 40 psi) capable of rupturing the catheter. " therefore, if the 3 ml syringe was used to infuse medications or to flush the catheter, this could have caused damage to the catheter. A review of the complaint database was conducted. No similar complaints were found related to this lot number.
 
Event Description
The product was inserted into the patient about 5 centimeters, but because the hospital did not get return flow, the nurse attempted to remove the catheter. The nurse had a hard time removing the catheter. The catheter was cut and 3 centimeters were left in the patient. A separate catheterization procedure was scheduled for (b)(6) 2015 date to remove the 3 centimeter section of product. Before the next catheterization could be performed, the patient had a cardiorespiratory arrest. The patient died on (b)(6) 2015. It was reported to argon by (b)(6) that the relationship of death to the device could not be confirmed. The patient was cardiac and had an unstable condition before using the device. No other information could be obtained regarding the patient other than the patient was a (b)(6) baby.
 
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Brand Name1ST PICC SIL S/L PED 2.8F X 50CM CATH
Type of Device1ST PICC
Manufacturer (Section D)
ARGON MEDICAL DEVICES, INC.
1445 flat creek drive
athens TX 75751
Manufacturer (Section G)
ARGON MEDICAL DEVICES, INC.
Manufacturer Contact
gail smith
1445 flat creek road
athens, TX 75751
2144368995
MDR Report Key5410852
MDR Text Key38102014
Report Number1625425-2015-00078
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K972262
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 02/03/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/04/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2017
Device Catalogue Number384101
Device Lot Number3357708
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/16/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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