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

Model Number 384101

Device Problems Difficult to Remove (1528); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/28/2022

Event Type  malfunction  

Event Description

"when trying to remove the guide wire, after passing the catheter and checking the x-ray, it presents resistance to removal, pulling the picc catheter along with it.Maneuvers are performed for its removal".

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 22GA (2.8F) 0.95MM X 50CM
• Type of Device: 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: 15248999
• MDR Text Key: 304034633
• Report Number: 0001625425-2022-01066
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00886333209644
• UDI-Public: 00886333209644
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K972262
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2023
• Device Model Number: 384101
• Device Catalogue Number: 384101
• Device Lot Number: 11306332
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention