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U.S. Department of Health and Human Services

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

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ARGON MEDICAL DEVICES INC. L-CATH 26G (1.9F)0.60MM X 30CM L-CATH PICC Back to Search Results
Catalog Number 384539
Device Problems Break (1069); Device Dislodged or Dislocated (2923)
Patient Problem Vomiting (2144)
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned for evaluation and no images or videos have been provided, so the complaint cannot be confirmed. If additional information is provided in the future, this issue will be reevaluated as needed.
 
Event Description
User placed this line in a (b)(6)-day old patient who needed it for long term antibiotics. The first incident, the line ¿fell¿ out of patient according to father of child. This had never happened before, so user believed that it may have been accidentally pulled out when dad reached for baby while she was vomiting. The next day, user placed the line again and 9 hours later, user noticed the line had actually slipped out 2cm through the plastic purple hub. User thought they had fixed the issue by securing the line where it was at. However, this morning user was made aware that the line actually snapped over weekend from hub and it was fortunately found quickly to prevent it from migrating into patient.
 
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Brand NameL-CATH 26G (1.9F)0.60MM X 30CM
Type of DeviceL-CATH 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 Key9187463
MDR Text Key169238794
Report Number1625425-2019-00268
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K091670
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/01/2005,09/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/08/2022
Device Catalogue Number384539
Device Lot Number11258658
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report to Manufacturer01/10/2005
Date Manufacturer Received09/18/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/14/2019 Patient Sequence Number: 1
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