MAUDE Adverse Event Report: ARGON MEDICAL DEVICES NEONATAL PROCEDURE TRAY

Model Number	384835
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is indicated as unavailable for evaluation.Without such evidence, the complaint cannot be confirmed.If additional information is received in the future, a follow-up report will be provided.
Event or Problem Description
We have had 3 failures this year - tubing not saved.All have been near the female end where the clave attaches.They were all long duration situations - at least weeks and i assumed were related to repetitive motion in that area since the rest of the extension is secured in a loop to protect the line from being pulled on accidentally.At least one failure had a clabsi event associated with it.Because of the motion issue with mechanical stress, i honestly didn't think there was a "problem" with the product.Extension sets changed.Picc left in place.One clabsi treated.No customer claim of set failure as the cause.

• Brand Name: NEONATAL PROCEDURE TRAY
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 10591821
• Report Number: 1625425-2020-00530
• Device Sequence Number: 2940771
• Product Code: OWL
• UDI-Device Identifier: 00886333210091
• UDI-Public: 00886333210091
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/25/2020

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: 384835
• Device Catalogue Number: 384835
• Device Lot Number: UNKNOWN
• 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: 09/28/2020
• 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