MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC S/L 18GA (4F) 1.35MM X 65CM

Model Number	384157
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 07/21, the patient was piccd for atb in a geriatric clinic, on 08/02 he was brought to the hospital because the catheter was fractured in the proximal portion close to the disc, it was necessary to change the catheter.
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.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no similar concerns were found.After three notifications, there has been no sample returned for evaluation.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, this complaint could not be confirmed and determining a definite root cause and corrective action is not possible.If the sample is returned at a future date, this complaint will be reopened for further evaluation at that time.
Event or Problem Description
On (b)(6), the patient was piccd for atb in a geriatric clinic, on (b)(6) he was brought to the hospital because the catheter was fractured in the proximal portion close to the disc, it was necessary to change the catheter.

• Brand Name: FIRST PICC S/L 18GA (4F) 1.35MM 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: 15250286
• Report Number: 0001625425-2022-01068
• Device Sequence Number: 5847228
• Product Code: FOZ
• UDI-Device Identifier: 00886333209682
• UDI-Public: 00886333209682
• 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): 10/11/2022

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: 05/11/2024
• Device Model Number: 384157
• Device Catalogue Number: 384157
• Device Lot Number: 11367559
• 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: 08/10/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 10/11/2022
• 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