MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM

Model Number	384242
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is indicated as returned.As of the date of this report, the sample has not been evaluated.A follow-up report will be provided once the device has been reviewed.
Event or Problem Description
Found that the iv fluids were "leaking" upon further investigation they found that the clear "tail" between the hub and the iv connection (the one with the writing on it) had split vertically.
Event or Problem Description
Found that the iv fluids were "leaking" upon further investigation they found that the clear "tail" between the hub and the iv connection (the one with the writing on it) had split vertically.
Additional Manufacturer Narrative
A review of the dhr and inspection records could not be conducted since a lot number was not provided.One opened catheter was returned for review.The catheter was disconnected from the extension line and was tested with a colored water filled syringe.Bubbles appeared along the silicone extension between the hub and the oval disc.Examination of the area under magnification confirmed a slit in the silicone which would result in leakage.The most probable cause for the damage to the catheter was most likely related to the user environment and not a manufacturing error.There have been no other complaints regarding this issue with this part number.Since the reported issue was most likely related to the user environment and not a manufacturing error, no corrective action will be taken at this time.Argon will continue to monitor for issues of this nature in the future.

• Brand Name: FIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM
• Common Device Name: FIRST PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 16903378
• Report Number: 0001625425-2023-01048
• Device Sequence Number: 5458666
• Product Code: FOZ
• UDI-Device Identifier: 00886333209774
• UDI-Public: 00886333209774
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K972262
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2023

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: 01/28/2025
• Device Model Number: 384242
• Device Catalogue Number: 384242
• Device Lot Number: 11434586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown