MAUDE Adverse Event Report: CAREFUSION, INC PLEURX; 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	09/26/2025
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.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 that during use of the pleurx pleural catheter mini kit, the safety valve broken / damaged / disconnected causing a valve leak.Although drainage was successful, the valve leaked when the drainage bag was disconnected.The issue was resolved by replacing the valve.There was no reported patient injury or exposure to bodily fluids occurred.
Event or Problem Description
It was reported that during use of the pleurx pleural catheter mini kit, the safety valve broken / damaged / disconnected causing a valve leak.Although drainage was successful, the valve leaked when the drainage bag was disconnected.The issue was resolved by replacing the valve.There was no reported patient injury or exposure to bodily fluids occurred.
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 g (component code), annex b (type of investigation), annex c (investigation findings), annex d (investigation conclusions).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.

• Brand Name: PLEURX
• 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: 23303804
• Report Number: 1423507-2025-00103
• Device Sequence Number: 4863851
• 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): 01/06/2026

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: 09/26/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 01/06/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown