MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. 1ST PICC S/L 26GA 1.9F X50C; FIRST PICC

Catalog Number 384232

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problems Unspecified Infection (1930); Pneumonia (2011)

Event Date 02/17/2014

Event Type  Injury  

Event Description

The patient had (b)(6) of life and was born at (b)(6) weeks.Ar/056 catheter breakage occurred on (b)(6) 2014, the nurse reported that the catheter had migration to the inferior vena cava, because it was inserted into the inguinal region.While the nurse was caring for another patient, the patient had migration of the catheter and was transferred to another hospital for heart surgery.Additional information received on (b)(6) 2014: the child was transferred to a pediatric hospital and they managed to withdraw the catheter catheterization, hemodynamics (it was not necessary to open surgery), and due to the transfer to the hospital for the catheter removal, a framework for infection and pneumonia was triggered.

Manufacturer Narrative

The catheter broke and it was noted that the catheter migrated to the inferior vena cava, because it was inserted into the inguinal region.The child was transferred to a pediatric hospital and the catheter was withdrawn and removed without surgery.When questioned about the maintenance of the catheter, it was reported by the nurse coordinator that a flushing pump was used to flush the catheter.Under cautions and warnings, the ifu states "never use catheter for high-pressure injections.Syringes smaller than 10 ml and mechanical high-pressure injectors can generate pressures capable of rupturing the catheter." the complaint product was not returned for evaluation.Catheters are 100 inspected at various stages during the manufacturing process.A pressure test is performed on all catheters during manufacturing to ensure the catheters can withstand the pressures and forces when utilized within the instructions for use.A control pull test is also performed per the specifications to ensure catheter strength and integrity.No discrepancies or nonconformaties were noted in the dhr per a report from the supplier.

• Brand Name: 1ST PICC S/L 26GA 1.9F X50C
• Type of Device: FIRST PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.; athens TX
• Manufacturer Contact: gail smith ; 1445 flat creek rd.; athens, TX 75751 ; 9722102562
• MDR Report Key: 3716055
• MDR Text Key: 16777795
• Report Number: 1625425-2014-00010
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K944504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/20/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: 384232
• Device Lot Number: 3060502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2014
• Initial Date FDA Received: 03/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 10 DA