MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC S/L 16GA (5F) 1.70MM X 65CM

Model Number	384158
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
Event or Problem Description
Hospitalized patient, diagnosed with chf, performed picc passage on (b)(6), on (b)(6) when taking medication, it was observed that the catheter was leaking, it was observed that the catheter was ruptured in the distal third in the first cm.
Additional Manufacturer Narrative
According to the customer, the sample was not available for review.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, the results are inconclusive and determining a root cause and corrective action is not possible.
Event or Problem Description
Hospitalized patient, diagnosed with chf, performed picc passage on (b)(6), on (b)(6) when taking medication, it was observed that the catheter was leaking, it was observed that the catheter was ruptured in the distal third in the first cm.

• Brand Name: FIRST PICC S/L 16GA (5F) 1.70MM X 65CM
• 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: 15251977
• Report Number: 0001625425-2022-01072
• Device Sequence Number: 14905021
• Product Code: FOZ
• UDI-Device Identifier: 00886333209699
• UDI-Public: 00886333209699
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2022

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
• Device Expiration Date: 05/05/2024
• Device Model Number: 384158
• Device Catalogue Number: 384158
• Device Lot Number: 11366453
• Was Device Available for Evaluation?: No
• 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: 08/11/2022
• Supplement Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown