MAUDE Adverse Event Report: CAREFUSION, INC UNK PLEURX; APPARATUS, SUCTION, PATIENT CARE

Catalog Number UNKNOWN

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 11/30/2023

Event Type  malfunction  

Event Description

Verbatim: rcc received a complaint via phone.Pir attached.Dr was reporting case on behalf of patient, customer the patient already has the pleurx installed.No, the product is fine, but he cannot be drained without supplies.He has leaking around the catheter.Customer is requesting replacements.(b)(6) phone number.Customer does not speak english.Product needed is drainage supplies for a tunneled peritoneal catheter drainage.He pleurx is leaking is because he is not being drained and he is exploding with fluid.The product did not fail.

Manufacturer Narrative

(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a050401.Patient problem code: f24.

Event Description

It was reported by consumer that dr was reporting case on behalf of patient , customer the patient already has the pleurx installed no, the product is fine, but he cannot be drained without supplies.He has leaking around the catheter.Customer is requesting replacements.(b)(6) phone number.Customer does not speak english.Product needed is drainage supplies for a tunneled peritoneal catheter drainage.He pleurx is leaking is because he is not being drained and he is exploding with fluid.The product did not fail.Verbatim: dr was reporting case on behalf of patient , customer the patient already has the pleurx installed, no, the product is fine, but he cannot be drained without supplies.He has leaking around the catheter.Customer is requesting replacements.(b)(6) phone number.Customer does not speak english.Product needed is drainage supplies for a tunneled peritoneal catheter drainage.He pleurx is leaking is because he is not being drained and he is exploding with fluid.The product did not fail.

Manufacturer Narrative

Pr (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.H3 other text : see manufacture narration.

• Brand Name: UNK PLEURX
• 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: 18380437
• MDR Text Key: 331359516
• Report Number: 1625685-2023-00125
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• 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