MAUDE Adverse Event Report: CAREFUSION, INC UNK PLEURX; PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 10/27/2023

Event Type  Injury  

Manufacturer Narrative

Pr (b)(4) initial emdr submission.Device problem code: a26.Patient problem code: f24.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 by customer that pleurx tube becoming infected.Verbatim: complaint received via email.I am in a dialysis group on facebook, and i saw this comment while i was scrolling through yesterday.I noticed that the comment mentions a pleurx catheter becoming infected, so i wanted to share it as a complaint.However, i do not know this person, nor do i have any additional information.My dad has cirrhosis of the liver, not alcohol induced, and retains a lot of fluid in his abdomen.He gets drained weekly for his fluid and pull 406 liters of fluid from his abdomen and it helps him tremendously.We go to ir for it.He had pleurx tube to do it himself and it worked well for awhile but eventually became infected.

• Brand Name: UNK PLEURX
• Type of Device: PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING
• 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: 18103627
• MDR Text Key: 327752687
• Report Number: 1625685-2023-00106
• Device Sequence Number: 1
• Product Code: PNG
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2023
• 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