MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC S/L 22GA (2.8F) 0.95MM X 50CM

Model Number	384101
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
We have a 2.8fr non power argon single lumen picc that broke on (b)(6) 2022.It was placed on (b)(6) 2022.I can provide more details to the correct person/department.¿ sent email to (b)(6) 2022 requesting additional information ¿ awaiting response, sent email to (b)(6) 2022 requesting additional information ¿ awaiting response.Update as of (b)(6) 2022 @ 1709- per (b)(6)¿the picc was leaking, took down dressing, picc broke, & estimated blood loss 1-2cc¿.
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
We have a 2.8fr non power argon single lumen picc that broke on 8/12/22.It was placed on 7/26/22.I can provide more details to the correct person/department.¿ sent email to lana 8/30/2022 requesting additional information ¿ awaiting response sent email to lana 9/2/2022 requesting additional information ¿ awaiting response update as of 9/2/2022 @ 1709- per lana ¿the picc was leaking, took down dressing, picc broke, & estimated blood loss 1-2cc¿.
Additional Manufacturer Narrative
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.

• Brand Name: FIRST PICC S/L 22GA (2.8F) 0.95MM 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: 15403452
• Report Number: 0001625425-2022-01085
• Device Sequence Number: 12500815
• Product Code: FOZ
• UDI-Device Identifier: 00886333209644
• UDI-Public: 00886333209644
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2022

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: 384101
• Device Catalogue Number: 384101
• 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: 08/30/2022
• Supplement Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 10/22/2022
• 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