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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM

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ARGON MEDICAL DEVICES L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM Back to Search Results
Model Number 384539
Device Problems Crack (1135); Fluid/Blood Leak (1250)
Patient Problem Insufficient Information (4580)
Event Date 02/25/2022
Event Type  malfunction  
Event Description
Picc placed on (b)(6) 2022 @ 1954pm.Picc hub cracked and leaking on (b)(6) 2022.Picc d/c¿ed.New picc line placed because patient on tpn, lipids, antibiotics.
 
Manufacturer Narrative
The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
 
Event Description
Picc placed on (b)(6) 2022 @ 1954pm.Picc hub cracked and leaking on (b)(3) 2022.Picc d/c¿ed.New picc line placed because patient on tpn, lipids, antibiotics.
 
Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no similar concerns were found.One sample was returned for review.The returned section of the catheter included the strain relief and catheter only.It was stated that the y piece could not be removed and hemostats had to be used to remove it.Based on the provided information, this complaint is confirmed.It could not be determined if the components were overtightened during assembly, packaging, or in the user environment.Since there is a possibility the components were overtightened during the assembly of the device, a training has been conducted with a previous complaint for the same issue since the manufacturing of this lot.
 
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Brand Name
L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM
Type of Device
L-CATH PICC
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX 75751
Manufacturer Contact
elnaz rahman
1445 flat creek rd
athens, TX 75751
9036759321
MDR Report Key13860218
MDR Text Key295899461
Report Number0001625425-2022-00965
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00886333209934
UDI-Public00886333209934
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 Health Professional,User Facility
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 04/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number384539
Device Catalogue Number384539
Device Lot Number11401159
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/14/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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