MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM

Model Number 384232

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/10/2024

Event Type  malfunction  

Manufacturer Narrative

The product was returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be submitted upon investigation completion.

Event Description

The reporter indicated the patient's mom was transferring baby and np walked in the room and saw peripherally inserted central catheter (picc) line on the floor.There was no patient injury.

Manufacturer Narrative

A review of the dhr and inspection records for the lot could not be conducted since a lot number was not provided.One opened sample was returned for review.Visual inspection confirmed breakage just below the inverted triangle underneath the silicone disc.Inspection under the microscope confirmed jagged edges which is indicative of a tensile force being applied to the catheter.Based on the review of the returned opened sample, the most probable cause for the breakage was most likely due to an event within the user environment.Possibly an excessive force was applied to the catheter that resulted in the breakage.The customer stated the parent transferred the baby.Since the breakage was most likely related to the user environment and not a manufacturing error, no corrective action will be taken at this time.Additional information provided in h.3., h.6.And h.9.

• Brand Name: FIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM
• Type of Device: FIRST PICC S/L
• 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: 18872183
• MDR Text Key: 337304558
• Report Number: 0001625425-2024-00955
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00886333209750
• UDI-Public: 00886333209750
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 03/09/2024

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: 384232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/10/2024
• Initial Date FDA Received: 03/10/2024
• Was Device Evaluated by Manufacturer?: No
• 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