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

Model Number	50-7280
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr: (b)(4).Initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a140901.Patient problem code: f26.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 or Problem Description
It was reported by the customer that product was clogged.Question: caller states they are working with a patient in the er who has a pleurx pleural catheter that is clogged.Caller asking how to flush this catheter and what is the priming volume.Caller asking if it is okay to use cathflo to help unclog the catheter.What dose of cathflo should they use? should this be done under imaging? response: provided 2.6ml to the first fenestration and 4.2ml to the end if the catheter.Explained that cathflo can be used to help unclog the catheter.Bd does not provide dosage recommendation for cathflo.Suggested they follow the package insert for cathflo.Nd doses not have recommendation regarding if imaging should be used.Confirmed that imaging will be dependent on institution protocol.Emailed catalog excerpt for the pleurx catheter kit- product code/ reference number: 50-7280.I would check with centeral supply and see if you have this product code or check with a neighboring hospital who might have this item.Using any other device to access the catheter could damage the catheter valve.On (b)(6) 2023: successful drainage completed.No patient harm that is know at this time.Line flushed well.Line was in left pleural space, unsure when placed.On (b)(6) 2023: unclear if was occluded, didn't appear to be drainage line.No pic.

• Brand Name: PLEURX PLEURAL CATHETER
• Common Device Name: 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: 16229419
• Report Number: 1625685-2023-00005
• Device Sequence Number: 20202057
• Product Code: DWM
• UDI-Device Identifier: 10885403185694
• UDI-Public: (01)10885403185694
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K160450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2023

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
• Operator of Device: Health Professional
• Device Model Number: 50-7280
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown