MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC D/L 18GA (3.5F) 1.20MM X 60CM

Model Number	18GA (3.5F) 1.20 MM X 60 CM
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample device is indicated as available for evaluation.As of the date of this report the sample has not yet been returned.A follow-up report will be provided once the sample is received and reviewed.
Event or Problem Description
We had another one crack at the hub again last night.This brings our total to 7 over the last five months.(b)(6): ¿ was there any harm to the patient.No, just an additional trip to ir to have a new line placed.¿ was a new picc placed to continue prescribed therapy.Yes, a 4 fr dl bard.¿ was a new piv placed to continue prescribed therapy.Yes.¿ was a needles connector placed on the hub of the red and blue lumens.Yes.¿ is the product available to be returned to argon quality for product evaluation/investigation.Yes.¿ what is the lot# of the product.11293336.
Additional Manufacturer Narrative
H3 other text: placeholder.
Event or Problem Description
Follow up.

• Brand Name: L-CATH PICC D/L 18GA (3.5F) 1.20MM X 60CM
• Common Device Name: L-CATH PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 10140872
• Report Number: 1625425-2020-00348
• Device Sequence Number: 13965742
• Product Code: FOZ
• UDI-Device Identifier: 00886333209866
• UDI-Public: 00886333209866
• Combination Product (Y/N): N
• Initial Reporter State: WA
• PMA/510(K) Number: K091670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 18GA (3.5F) 1.20 MM X 60 CM
• Device Catalogue Number: 384467
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 07/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1