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	Insufficient Information (4580)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation and the investigation is in progress.A follow-up report will be provided once the investigation has been completed.
Event or Problem Description
Item #384467/lot# 1128391 was inserted on (b)(6) 2020.On the 53rd day of dwell the hub experienced a little crack then split down the middle.Picc removed.New picc placed for completion of prescribed therapy.
Event or Problem Description
Follow up.
Additional Manufacturer Narrative
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• 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: 10656178
• Report Number: 1625425-2020-00603
• Device Sequence Number: 3174670
• Product Code: FOZ
• UDI-Device Identifier: 00886333209866
• UDI-Public: 00886333209866
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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 Practitioner
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Device Lot Number: 1128391
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/05/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other