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

Catalog Number	UNKNOWN
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported: customer had infection event description states: - what was the impact to the patient? after pt was not able to suction made appointment with dr, then dr sent pt to hospital, where they were treated with iv antibiotics tube was removed after it was determined that the infection was caused by the catheter in pt wall, pt was released 18th mar.Customer was contacted regarding reported issue with product received from edge park distributors, customer reported that after visiting the doctor regarding an infection at catheter placement site, doctor ordered patient admittance into hospital for iv antibiotics and catheter removal.-was there infection noticed at the insertion site? yes - what was the cause of the infection? customer, former rn said she felt that it was from the device.- was there a leakage at the insertion site? yes, she said there was in addition to redness and swelling - was there any damage noticed on catheter valve? no - was there any damage noticed on the catheter? no - was there any issue with the pleurx bottle lead to the infection? unknown - was there any medical intervention required including diagnostics, procedures, and treatment delay? yes, iv antibiotic treatment, catheter removal - lot number and material number associated with pleurx catheter if there is issue with the pleurx catheter? unknown.
Additional Manufacturer Narrative
(b)(4) initial emdr submission.Device problem code: a050401 patient problem code: f1903 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.

• Brand Name: UNKNOWN PLEURX
• 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: 19043411
• Report Number: 1625685-2024-00030
• Device Sequence Number: 7242567
• Product Code: DWM
• UDI-Device Identifier: 10885403090707
• UDI-Public: (01)10885403090707
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 04/04/2024
• 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