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	08/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is indicated as unavailable for evaluation.Without the sample or any visual evidence to review, the complaint cannot be confirmed.If additional information is received in the future, a follow-up report will be provided.
Event or Problem Description
There have been 8 occasions that when the picc is about 1 month old and the male portion of iv tubing connected and tightened to hub, the hub is getting a little crack then splits down the middle.

• 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: 10478080
• Report Number: 1625425-2020-00496
• Device Sequence Number: 3538701
• 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
• Report Date (Section B): 09/01/2020

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1