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	Insufficient Information (4580)
Date of Event	08/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.Without any evidence to review, the complaint cannot be confirmed.Careful handling is required during the procedure as not to cause damage to the soft silicone catheter.The ifu warns users: catheters should be flushed after each infusion to clear infused medication from the catheter lumen, thereby reducing the risk of contact between incompatible medications.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.Solutions containing high concentrations of alcohol can temporarily weaken the structure of polyurethane material.For polyurethane catheters, minimize exposure to alcohol solutions.Do not expose the catheter to acetone or acetone/alcohol solutions.Do not use if package is opened or damaged.Do not cut stylet.If cut, stylet can potentially damage the catheter and harm the patient.Never use force to advance the catheter.Resistance could indicate a vein obstruction or malposition of the catheter.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.Syringes smaller than 10 ml can generate high pressures (greater than 40 psi) capable of rupturing the catheter.Never place tape strips over the catheter tubing.This will compromise the strength and integrity of the tubing.Catheters should be flushed after each infusion to clear infused medication from the catheter lumen, thereby reducing the risk of contact between incompatible medications.
Event or Problem Description
Newborn with picc catheter inserted on (b)(6) 2021, receiving continuous infusion of basal saline solution by infusion pump, serum leakage was observed in the bed, the catheter was washed, and it was found to be punctured.

• 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
• MDR Report Key: 12565605
• Report Number: 0001625425-2021-01089
• Device Sequence Number: 4231431
• 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): 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 384221
• Device Catalogue Number: 384221
• Device Lot Number: 11353870
• 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: 09/10/2021
• Initial Report FDA Received Date: 10/01/2021
• 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