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

Model Number 384221

Device Problem Break (1069)

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

Event Date 06/16/2022

Event Type  malfunction  

Manufacturer Narrative

The sample is not available for return.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.

Event Description

Breakage of the introducer at the time of passage, preventing the catheter from passing through.

Manufacturer Narrative

A review of the dhr and inspection records was conducted, and no similar concerns were found.According to the customer, there was no sample available for review.Additionally, there was no visual evidence provided to support the reported issue.Without such evidence, this complaint could not be confirmed.According to the customer, there was no sample available for review.Additionally, there was no visual evidence provided to support the reported issue.Without such evidence, this complaint could not be confirmed and determining a definite root cause and corrective action is not possible.

Manufacturer Narrative

Udi related data quality updates only.

• Brand Name: FIRST PICC S/L 26GA (1.9F) X 50CM 1 LUMEN
• Type of Device: FIRST PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 19139522
• MDR Text Key: 340800609
• Report Number: 0001625425-2024-00990
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00886333209743
• UDI-Public: (01)00886333209743(17)250404(10)11427029
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972262
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2024

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 Operator: Health Professional
• Device Model Number: 384221
• Device Lot Number: 11427029
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 06/12/2024; 08/24/2024
• Supplement Dates FDA Received: 07/11/2024; 08/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1