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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC¿ S/L 26GA (1.9F) 0.65MM X 50CM

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ARGON MEDICAL DEVICES FIRST PICC¿ S/L 26GA (1.9F) 0.65MM X 50CM Back to Search Results
Model Number 384232
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 01/08/2022
Event Type  malfunction  
Event Description
Picc line found broken when checking infant. Nnp removed. Remainder of catheter intact. Inserted by (b)(6) on (b)(6) 2021 ¿c 25 cm. ¿ no longer have prg. ¿.
 
Manufacturer Narrative
According to the product experience report, there was no sample to be returned. Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed. Without such evidence, this complaint could not be confirmed and determining a definite root cause and corrective action is not possible. If the sample is returned at a future date, a follow-up report will be submitted.
 
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Brand NameFIRST PICC¿ S/L 26GA (1.9F) 0.65MM X 50CM
Type of DeviceFIRST 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 Key13659161
MDR Text Key289252321
Report Number0001625425-2022-00953
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00886333209750
UDI-Public00886333209750
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K972262
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility
Reporter Occupation
Type of Report Initial
Report Date 03/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number384232
Device Catalogue Number384232
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/03/2022 Patient Sequence Number: 1
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