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

Model Number 384232

Device Problems Leak/Splash (1354); Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Date 08/17/2021

Event Type  malfunction  

Manufacturer Narrative

The sample was returned for evaluation.A follow-up report will be submitted once the investigation has been completed.

Event Description

Iv pump began alarmed for occlusion around 0500.Rn investigated.Rn stopped infusion and attached saline flush.Upon flushing, rn noted leaking from the port/hub of the picc line (from the clear jelly part of the line).Rn notified physician.Physician ordered to place piv and dc picc line.Poc lytes and glucose obtained and indicated no concern in infants imminent nutritional status.Line likely failed only moments before occlusion alarm.No wetness was noted on infants linens.¿ was a new piv or picc placed: ¿yes.Scalp piv.Infant very difficult iv stick and currently npo due to r/o nec.¿.

Manufacturer Narrative

A review of the sample found breakage above the securement disc, confirming the complaint.Under magnification, a horizontal cut was observed at the leakage site.Careful handling is required during the procedure as not to cause damage to the soft silicone catheter.The ifu warns users: 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 Description

Iv pump began alarmed for occlusion around 0500.Rn investigated.Rn stopped infusion and attached saline flush.Upon flushing, rn noted leaking from the port/hub of the picc line (from the clear jelly part of the line).Rn notified physician.Physcian ordered to place piv and dc picc line.Poc lytes and glucose obtained and indicated no concern in infants imminent nutritional status.Line likely failed only moments before occlusion alarm.No wetness was noted on infants linens.¿ was a new piv or picc placed: ¿yes ¿ scalp piv ¿ infant very difficult iv stick and currently npo due to r/o nec.¿.

• Brand Name: FIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM
• Type of Device: FIRST PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• MDR Report Key: 12425027
• MDR Text Key: 271299010
• Report Number: 0001625425-2021-01072
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00886333209750
• UDI-Public: 00886333209750
• 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
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 384232
• Device Catalogue Number: 384232
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other