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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 COMPLETE KIT L-CATH PICC

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ARGON MEDICAL DEVICES INC. L-CATH 26G (1.9F)0.60MM X 30CM COMPLETE KIT L-CATH PICC Back to Search Results
Catalog Number 384559
Device Problem Leak/Splash (1354)
Patient Problem Unspecified Infection (1930)
Event Date 08/28/2019
Event Type  malfunction  
Manufacturer Narrative
One catheter was returned for review. Visual inspection of the catheter found that the catheter hub was cracked. The device was also functionally tested, and leakage through the cracked luer cap was confirmed. The exact root cause is unable to be determined; however, a probable cause of the cracked hub is related to excessive force being applied to the catheter hub during use.
 
Event Description
User experienced an issue with the 26ga picc. 8 days after insertion, the picc leaked and appeared to crack. An investigation is being done at the local level as the patient tested positive for blood stream infection. Picc inserted on 8/21. Picc removed 8/28 due to leaking, staff reported that the catheter itself was cracked. A new picc or piv was placed for patient to finish prescribed therapy.
 
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Brand NameL-CATH 26G (1.9F)0.60MM X 30CM COMPLETE KIT
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 Key9183773
MDR Text Key169237952
Report Number1625425-2019-00266
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 Date07/01/2020
Device Catalogue Number384559
Device Lot Number11263215
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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