MAUDE Adverse Event Report: COOK INC DOUBLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number PICDS-601-MPIS

Device Problems Material Rupture (1546); Device Operational Issue (2914)

Patient Problems Allergic reaction (1701); Distress (2329)

Event Type  malfunction  

Event Description

A (b)(6) pt who requires silicone piccs every 3 months or so, has been having issues with the lumen popping.One of the 2 lumens looked like it was about to pop, causing much stress.The line is also being used for iv hydration at home and some prn meds in the hosp.The line has been installed approximately month and the pt has reacted with severe irritation to polyurethane pics and have done better with silicone.The pop happened 2 weeks in one of the small lumen.Now the large line is threatening to pop and is not working at all.A section of the device did not remain inside the patient's body.The pt did not require any additional procedures due to this occurrence.According to the initial reporter, the pt did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

The event is currently under investigation.More info will be provided upon conclusion.

Manufacturer Narrative

(b)(4).No product was returned to assist in the investigation, however, a review of complaint history, instructions for use (ifu) and quality control (qc) was conducted.Per quality control (qc) specification, the qc personnel are instructed to check that the surface is clean and free of any surface imperfections as well as ensuring the assembly will withstand appropriate pressure.The overall catheter surface is confirmed to be clean and free of damage or excessive imperfections and that the small lumen is open, clear and aligned with appropriate extension and no lumen communication.This product is shipped with an instructions for use (ifu), which states under warnings "silicone peripherally inserted central venous catheters are not designed for power injection of contrast medium catheter rupture may occur.Use of a 10 ml or larger syringe will reduce the risk of catheter rupture." it also states under precautions "if lumen flow is impeded, do not force injection or withdrawal of fluids notify attending physician immediately." the ifu also provides information regarding catheter maintenance and instructions for use.Based on the information provided that the patient was using a 6 ml syringe and not the recommended 10 ml syringe, it is possible that the catheter was exposed to excessive pressure.The appopriate internal personnel have been notified and we will continue to monitor for similar complaints.The quality engineering risk assessment (qera) concluded that no further risk reduction is required.

Event Description

A (b)(6) y/o pt who requires silicone picc's every 3 months or so, has been having issues with the lumen popping.One of the 2 lumens looked like it was about to pop, causing much stress.The line is also being used to iv hydration at home and some prn medications in the hospital.The line has been installed approx 1 month and pt has reacted with severe irritation to polyurethane picc's and have done better with silicone.The pop happened 2 weeks in one of the small lumen.Now the large line is threatening to pop and is not working at all.A section of the device did not remain inside the pt's body.The pt did not require any add'l procedures nor experience any adverse effects due to this occurrence.

• Brand Name: DOUBLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; bloomington IN 47404
• Manufacturer Contact: larry pool, mgr ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4576398
• MDR Text Key: 5449245
• Report Number: 1820334-2015-00106
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 01/29/2015

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: Lay User/Patient
• Device Catalogue Number: PICDS-601-MPIS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/29/2015
• Device Age: NA
• Event Location: Home
• Initial Date Manufacturer Received: 01/30/2015
• Initial Date FDA Received: 02/25/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR