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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC SINGLE LUMEN 28GA (1.2F) X 25CM

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ARGON MEDICAL DEVICES L-CATH PICC SINGLE LUMEN 28GA (1.2F) X 25CM Back to Search Results
Model Number 28 GA (1.2F) X 25CM
Device Problems Crack (1135); Fluid Leak (1250); Flushing Problem (1252)
Patient Problem Insufficient Information (4580)
Event Date 09/03/2020
Event Type  malfunction  
Manufacturer Narrative
The device is indicated as available for evaluation. As of the date of this report, it has not been returned. A follow-up report will be provided once the device has been received and reviewed.
 
Event Description
Picc placed in neonate. Once inserted, the physician attempted to flush the picc to lock it before xray. The rigid y piece was leaking and noted to be cracked at that time. It was removed and our clave was added. The physician was unable to flush the picc even after manipulation of the line. The picc was removed and multiple subsequent attempts were unsuccessful.
 
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Brand NameL-CATH PICC SINGLE LUMEN 28GA (1.2F) X 25CM
Type of DeviceL-CATH PICC
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX
Manufacturer Contact
gina liu
1445 flat creek rd, athens, tx 75751
MDR Report Key10555450
MDR Text Key208314915
Report Number1625425-2020-00527
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K091670
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 09/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number28 GA (1.2F) X 25CM
Device Catalogue Number384539
Device Lot Number11274855
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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