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

Catalog Number	50-7050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11:as the lot number for the device was not provided, a review of the device history records has not been performed.The device was not returned.The investigation is currently underway.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.Section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported by customer that pleurx pleural valve is damaged.No medical intervention was required, and there was no exposure to blood or body fluids.There was no reported patient injury.The issue was resolved by replacing the valve.The catheter had been in place since (b)(6) 2025.
Event or Problem Description
It was reported by customer that pleurx pleural valve is damaged.No medical intervention was required, and there was no exposure to blood or body fluids.There was no reported patient injury.The issue was resolved by replacing the valve.The catheter had been in place since (b)(6) 2025.
Additional Manufacturer Narrative
H11: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A device history record could not be evaluated as the lot number is unknown.Based on the available information we are not able to identify a root cause at this time.The complaint has been logged in the complaint management system and will be monitored through tracking, trending, and quality data analysis for potential future occurrences.G3 (date received by manufacturer), g6 type or report - follow up# 1), h2 (correction and additional information), h6: annex b (type of investigation), annex c (investigation findings), annex d (investigation conclusions).Section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: PLEURX PLEURAL CATHETER MINI KIT
• Common Device Name: APPARATUS, SUCTION, PATIENT CARE
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: brett curtice_ ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 23790232
• Report Number: 1423507-2025-00176
• Device Sequence Number: 14839379
• Product Code: DWM
• UDI-Device Identifier: 10885403075988
• UDI-Public: (01)10885403075988
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2026

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 Catalogue Number: 50-7050
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown