MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC S/L 26GA (1.9F) X 50CM 1 LUMEN

Model Number	384221
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
"when washing the picc in the right upper limb with 0.9% saline solution prior to the installation of a new parenteral nutrition bag, serum leakage was observed in the external extension of the catheter.A new attempt to pass the picc was unsuccessful.Peripheral venous access was then punctured in the cephalic region with difficulty due to the newborn's clinical condition (capillary fragility and anasarca).Contaminated sample was discarded.".
Additional Manufacturer Narrative
According to the product experience report, there was no sample to be returned.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, a follow-up report will be submitted.

• Brand Name: FIRST PICC S/L 26GA (1.9F) X 50CM 1 LUMEN
• 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: 15254654
• Report Number: 0001625425-2022-01073
• Device Sequence Number: 17814523
• Product Code: FOZ
• UDI-Device Identifier: 00886333209743
• UDI-Public: 00886333209743
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/18/2022

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
• Operator of Device: Health Professional
• Device Model Number: 384221
• Device Catalogue Number: 384221
• Device Lot Number: 11386759
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 08/18/2022
• 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