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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 Leak/Splash (1354); Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/03/2019
Event Type  malfunction  
Manufacturer Narrative
The device history record was reviewed, and no similar concerns were noted. One catheter was returned for review. Visual inspection of the catheter found that the catheter tubing was separated from the hub. The exact root cause is unable to be determined based on the information available.
 
Event Description
A picc was leaking. Upon examination, the infant's picc dressing was saturated. The light purple sheath on the end of the picc had dislodged from the hub, and the picc line was moving through this sheath under the dressing. The resident was called to the bedside and ordered that the picc be removed. While removing the picc, the purple sheath completely disconnected from the hub.
 
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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 Key9183765
MDR Text Key169237606
Report Number1625425-2019-00264
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 01/01/2005,09/16/2019
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 Date03/11/2022
Device Catalogue Number384539
Device Lot Number11249993
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/24/2019
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 Received09/16/2019
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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