MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC S/L WITH STATLOCK STABILIZATION DEVICE

Model Number	384242
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is not available for return.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
Event or Problem Description
The reporter indicated they placed a single lumen picc on neonates on (b)(6) 2023 for the inpatient peds floor and has broken just prior to the disc under the tegaderm using the statlock.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no similar concerns were found.According to the customer, there was no sample available for review.However, an image was provided for this lot number that confirmed breakage just below the inverted triangle beneath the silicone disc.Therefore, this complaint was confirmed for breakage.A definite root cause for the breakage could not be determined without the sample to review.Based on the review of the provided image, it could not be determined if the catheter tubing was cut or if a tensile force had been applied which would leave jagged edges at the breakage area of the tubing.Since a definite root cause could not be established, no corrective action will be taken at this time.Argon will continue to monitor for issues of this nature in the future.
Additional Manufacturer Narrative
Udi related data quality updates only.

• Brand Name: FIRST PICC S/L WITH STATLOCK STABILIZATION DEVICE
• Common Device Name: FIRST PICC S/L
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 19189225
• Report Number: 0001625425-2024-00997
• Device Sequence Number: 8361404
• Product Code: FOZ
• UDI-Device Identifier: 00886333209774
• UDI-Public: (01)00886333209774(17)250428(10)11454701
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/24/2024

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: 04/28/2025
• Device Model Number: 384242
• Device Lot Number: 11454701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2024
• Supplement Date Received by Manufacturer: 07/12/2024; 08/24/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 07/01/2024; 08/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2022
• 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
• Patient Sex: Unknown