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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); Leak/Splash (1354); Physical Resistance/Sticking (4012)
Patient Problem Blood Loss (2597)
Event Date 08/26/2019
Event Type  malfunction  
Manufacturer Narrative
The investigation is ongoing and a follow up report will be submitted once the evaluation is complete.
 
Event Description
During iv medication push through picc line stopcock - resistance present - and a pop sound heard from the line so picc line dressing change during that procedure. The connection between the line and the hub detached (broken) so blood came out and line clamped right away with hemostat clamp. Dr. Aware (picc line inserted (b)(6) 2019). Bleeding from iv line stopped as soon as line clamped with hemo stat clamp. Picc line removed.
 
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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 Key9187458
MDR Text Key169238683
Report Number1625425-2019-00269
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)Y
Reporter Country CodeCA
PMA/PMN Number
K091670
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
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? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/04/2021
Device Catalogue Number384539
Device Lot Number11230638
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/01/2019
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 Received01/14/2005
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/04/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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