MAUDE Adverse Event Report: FIRST PICC S/L PERIPHERALLY INSERTED CENTRAL CATHETER

Model Number	384232
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample was returned to argon for investigation.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
Event or Problem Description
A report was received via medwatch indicating "small hole found in picc tubing." medical intervention was required.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted, and no deviations or non-conformances were recorded relating to this issue.One opened sample was returned for review.Functional testing of the device confirmed leakage where the tubing is inserted into the inverted triangle just below the oval disc.A closer examination of the area under magnification, found a puncture hole in the tubing which confirmed the complaint.Since the product was returned opened, a definite root cause for the damage to the catheter tubing could not be established.It could not be determined if the damage was the result of an event within the assembly, unit storage, or packaging of the product or if the damage was the result of an event within the user environment.The customer did not state if the hole was observed upon initial inspection or flushing of the device or if the defect was observed after the device was placed in the patient.Since a definite root cause could not be determined, an appropriate corrective action is not possible.Argon will continue to monitor for issues of this nature in the future.

• Brand Name: FIRST PICC S/L PERIPHERALLY INSERTED CENTRAL CATHETER
• Common Device Name: FIRST PICC S/L
• Manufacturer Contact: kelly mayer ; 1445 flat creek road; athens, TX 75751 ; 9036759321
• MDR Report Key: 20391256
• Report Number: 0001625425-2024-01115
• Device Sequence Number: 12403695
• Product Code: FOZ
• UDI-Device Identifier: 00886333209750
• UDI-Public: (01)00886333209750(17)270215(10)11560144
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

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: 384232
• Device Lot Number: 11560144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2024
• 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: Required Intervention
• Patient Age: 7 DA
• Patient Sex: Male
• Patient Weight: 2 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White