MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. 1ST PICC S/L 26GA

Catalog Number 384232

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/09/2016

Event Type  malfunction  

Manufacturer Narrative

The device history record could not be reviewed because the lot number was not provided.There was no patient injury.The picc broke and had to be removed.Visual inspection of returned product confirmed the breakage, which occurred just below the nose of the overmolded extension set.The area of separation was reviewed under magnification.The tubing appeared to have been fully formed (no voids were noted).The edges of the separated tubing were jagged which is characteristic of undue force to the catheter.Potential times at which this force may have been applied to the catheter include: flushing the catheter with excessive pressure, such as flushing with a syringe smaller than 10 ml, or applying pressure despite resistance when flushing.Using the catheter for high pressure mechanical injection.Advancing or removing the catheter despite experiencing resistance.The ifu includes the following guidelines to inform clinicians of these causes and mitigate the occurrence of breakage: "use a 10 ml syringe design to flush the catheter.Do not use force to flush the catheter as a 10 ml syringe design has the potential to generate high pressure (greater than 40 psi) capable of rupturing the catheter." "never use force to flush the catheter if resistance is met." "never use the catheter for high-pressure injection.Syringes smaller than 10 ml and mechanical high-pressure injectors can generate pressures capable of rupturing the catheter." this complaint may be related to the handling of the device in the user environment.

Event Description

The picc broke off just below argon label.Picc was removed all of catheter was intact.Piv was inserted after this product was discontinued so the patient was able to complete the prescribed therapy.

• Brand Name: 1ST PICC S/L 26GA
• Type of Device: 1ST PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek road; athens TX 75751
• Manufacturer (Section G): ARGON MEDICAL DEVICES, INC.
• Manufacturer Contact: gail smith ; 1445 flat creek road; athens, TX 75751 ; 2144368995
• MDR Report Key: 5515320
• MDR Text Key: 41075841
• Report Number: 1625425-2015-00098
• Device Sequence Number: 1
• Product Code: FOZ
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/21/2016

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 Catalogue Number: 384232
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2016
• Initial Date FDA Received: 03/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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