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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is indicated as unavailable for evaluation.Without the sample or 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
Item #384467/lot# 11267058 was inserted (date unavailable).On the 32nd day of dwell the hub experienced a little crack then split down the middle.
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: 10483647
• Report Number: 1625425-2020-00501
• Device Sequence Number: 19717453
• 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): 09/02/2020

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 Expiration Date: 10/21/2022
• Device Model Number: 18GA (3.5F) 1.20 MM X 60 CM
• Device Catalogue Number: 384467
• Device Lot Number: 11281124
• 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: 09/02/2020
• 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