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

Model Number 384221

Device Problem Fracture (1260)

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

Event Date 04/22/2021

Event Type  malfunction  

Manufacturer Narrative

Sample expected to return for evaluation.

Event Description

Picc catheter fractured right above plastic end piece.All of cath removed from pt.

Manufacturer Narrative

A review of one catheter returned from the customer found breakage at the securement disc, confirming the complaint.This failure is a known occurrence with the first picc catheters.The potential causes for catheter breakage/leakage are due to the user applying force flushing the catheter when feeling resistance, the user using hemostats or clamps on the catheter hub, the user placing tape strips on the catheter tubing, the user applying excessive force upon the catheter during use, biological material blockage causing rupture in the catheter, or patient movement while indwelling.The soft silicone catheter requires careful handling to prevent damage, especially at the junction near the securement disc where the catheter is at its most vulnerable point.The ifu provides instructions for proper catheter insertion including stylet removal, aspirating and flushing, securing the catheter and applying sterile dressing.The ifu instructs under cautions and warnings: do not use hemostats or clamps on catheter or hub connection.Never use catheter for high-pressure injection.Syringes smaller than 10 ml and mechanical high-pressure injectors can generate pressures capable of rupturing the catheter.Never use force to flush the catheter if resistance is met.Do not expose the catheter to acetone or acetone/alcohol solutions.Do not use if package opened or damaged.Do not cut stylet.If cut, stylet can potentially damage the catheter and harm the patient.Never use force to remove the stylet.Resistance can damage the integrity of the catheter and the stylet.Do not hold the catheter with forceps while removing the stylet.Never place tape strips over the catheter tubing.This will compromise the strength and integrity of the tubing.".

Event Description

Picc catheter fractured right above plastic end piece.All of cath removed from pt.

Manufacturer Narrative

The sample was returned and the investigation is in progress.A final report will be submitted once the investigation has been completed.

Event Description

Picc catheter fractured right above plastic end piece.All of cath removed from pt.

• 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
• MDR Report Key: 11853310
• MDR Text Key: 254824055
• Report Number: 0001625425-2021-00921
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00886333209743
• UDI-Public: 00886333209743
• Combination Product (y/n): N
• PMA/PMN Number: K972262
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2023
• Device Model Number: 384221
• Device Catalogue Number: 384221
• Device Lot Number: 11355581
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention