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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

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ARGON MEDICAL DEVICES, INC. L-CATH 26G (1.9F)0.60MM X 30CM Back to Search Results
Catalog Number 384539
Device Problems Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)
Patient Problems Cardiac Arrest (1762); Death (1802); Pericardial Effusion (3271)
Event Date 02/03/2016
Event Type  Death  
Manufacturer Narrative
Per information received by the sales representative from the customer, this complaint was not due to a product issue. This was a human error in regards to care/maintenance of the picc. An education/training has been scheduled. No additional information was provided by the customer.
 
Event Description
Notified by customer that there was a bio-patch over the picc insertion site. Four (4) cm of picc migrated inward and patient experienced a pericardial tamponade. Patient died. Per customer, this is not a product issue. This was a human error in regards to care/maintenance of the picc. No other details was provided by the customer. Per medwatch report (b)(4) which was received on march 21, infant had a picc line places on (b)(6) 2016, which has noted to have migrated into the heart and repositioned on two occasions. On (b)(6) 2016 had a sudden arrest and expired. Autopsy revealed a pericardial effusion with fluid consistent with total parenteral nutrition solution. Note: it was confirmed that this medwatch report was the same complaint that we had already received and entered in our complaint database under (b)(4).
 
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Brand NameL-CATH 26G (1.9F)0.60MM X 30CM
Type of DeviceL-CATH
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 Key5539734
MDR Text Key41612920
Report Number1625425-2016-00004
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091670
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 03/30/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/31/2018
Device Catalogue Number384539
Device Lot Number11122897
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/30/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/31/2016 Patient Sequence Number: 1
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