MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. FIRST PICC 26GA, SINGLE LUMEN

Catalog Number 384232

Device Problems Fluid/Blood Leak (1250); Split (2537)

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

Event Date 08/12/2017

Event Type  malfunction  

Manufacturer Narrative

There were no samples or images available for review; however, a lot number was provided.A review of the device history records and inspection records was conducted and no similar concerns were found.Without the sample to review, a definite root cause and corrective action cannot be established.First picc catheters are 100% in-process inspected at various times during manufacture.Catheters are also leak, flow, and burst tested to ensure their integrity.Additionally, the instructions for use indicate several ways users can prevent catheter damage.

Event Description

After platelet infusion, rn had flushed 5ml's of normal saline through the picc, picc flushed easily with no resistance.At 5ml's the picc split open, and normal saline gushed out of the line at the split.Rn immediately notified charge nurses.

• Brand Name: FIRST PICC 26GA, SINGLE LUMEN
• Type of Device: FIRST 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: 6886437
• MDR Text Key: 89379062
• Report Number: 1625425-2017-00133
• 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: other
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 384232
• Device Lot Number: 11179278
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2017
• 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
• Patient Outcome(s): Other
• Patient Age: 25 DA