MAUDE Adverse Event Report: ARGON MEDICAL DEVICES NEONATAL PROCEDURE TRAY

Model Number	384835
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was returned for evaluation.The investigation is ongoing.A follow-up report will be provided once it has been completed.
Event or Problem Description
I want to report that one of our new, converted piccs, argon lot #11259401, was leaking and caused the line to clot off.This resulted in the baby having to have another procedure to insert a new picc and puts the baby at risk for infection.I¿m fairly certain that this is the first time that we have used this new picc.This picc was placed in the right antecubital vein on a term baby for long term antibiotic use on tuesday, may 12th.The tubing was changed on thursday, may 14th and at that time just had a ¼ normal saline with 0.5 units heparin per ml running to keep open at 0.5ml an hour with intermittent medication doses of 6.6ml over 30 minutes every 8 hours.On saturday, may 16th at 1500 the to keep open rate was increased to 1ml/hr.At 1800 on the same day, the nurse noted that it was leaking.It was determined after troubleshooting by the rn and the nnp that it was the extension set (the short tubing that connects the picc to the tubing) was cracked at the female hub and was leaking from that site.It was removed from the picc and the tubing connected directly to the picc but by that time the line was noted to be clotted and had to be removed and replaced.I have the cracked extension set and will bring down tomorrow.I just wanted you guys to have this information for when it¿s reported to the manufacturer.
Event or Problem Description
Follow up.

• Brand Name: NEONATAL PROCEDURE TRAY
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 10222135
• Report Number: 1625425-2020-00380
• Device Sequence Number: 812001
• Product Code: OWL
• UDI-Device Identifier: 00886333210091
• UDI-Public: 00886333210091
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2020

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 Expiration Date: 07/01/2020
• Device Model Number: 384835
• Device Catalogue Number: 384835
• Device Lot Number: 11259401
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/24/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1