MAUDE Adverse Event Report: CAREFUSION, INC PLEUR X PLEURAL CATHETER; APPARATUS, SUCTION, PATIENT CARE

Catalog Number UNKNOWN

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/14/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).Follow-up emdr for device evaluation: no photos or physical samples that display the reported condition were available for investigation.A device history review could not be completed as no batch number was provided.Based on the available information we are not able to identify a root cause at this time.Should you experience any problems with our product, examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.

Event Description

It was reported that during a catheter placement procedure, the catheter allegedly had a leak.The procedure was completed using another device.There was no reported patient injury.Verbatim: it was reported that during a catheter placement procedure, the catheter allegedly had a leak.The procedure was completed using another device.There was no reported patient injury.I don¿t know the other things but implant was (b)(6) at (b)(6) medical center (b)(6).It is still in.Nurses drain it every day.It still leaks.Sometimes i pull of the cover a d tape more gauze pads over it.My question is am i doing something wrong like moving too much or laying on my side.Should i do anything differently? my catheter leaks and fluid breaks out of the clear plastic seal less than a day after draining.I went to the emergency department on saturday and again sunday (b)(6) and (b)(6) 2022.They drained 750 ml on saturday and 650 ml on sunday.This does not count what soaked the towel and shirts i had over it before going to the ed.Monday my oncologist is dr (b)(6) of (b)(6) medical center cancer center in (b)(6), affiliated with (b)(6) and part of the (b)(6) memorial hospital system.Dr told me to make an appointment with the interventional radiology unit at the hospital.They wanted to talk with dr (b)(6) first.They told him, sight unseen, that they would remove the existing catheter and replace it with a new one.Dr (b)(6) wasn¿t sure that was the right course of action.So dr (b)(6) sent me back to the interventional pulmonologist with (b)(6) dr (b)(6) who did a bronchoscope biopsy of the non small cell cancer mass in my lower left lobe at (b)(6) hospital in (b)(6) on (b)(6) 2022.I asked him if i needed another stitch in my skin around the tube.He said it looked good.He also said that it was properly positioned inside.He could see it on the pet scan he used during the bronchoscopy.He said that they move around but it¿s not a problem.We found that every time they drain it, very little comes out at first.I have to lay down and roll around on my side a bit to get it to empty.It is soaking the gauze but it hasn¿t broken out of the adhesive seal yet.A palliative card nurse is coming to my house between 1:00 and 1:30 this afternoon to drain it.(b)(6) 2022 1:14 pm: conversation with patient - verified that leakage was at insertion site - no pt harm - pt went to hospital, completed drainage while at hospital - no medical intervention provided based on two doctors evaluations of issue - pt is extremely pleased and happy with pleurx product.

• Brand Name: PLEUR X PLEURAL CATHETER
• Type of Device: APPARATUS, SUCTION, PATIENT CARE
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 14398449
• MDR Text Key: 300158017
• Report Number: 1625685-2022-00053
• Device Sequence Number: 1
• Product Code: DWM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2022
• 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