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

Catalog Number	UNKNOWN PLEURX
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
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.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 that the pleurx drainage kit plunger was defective.No patient harm was reported.During follow up response it was further reported that the drain valve broke.No patient impact was reported.Additional follow up received by the customer stated the piece connected to the catheter that is inserted in the patient's lung is the component that broke and that the bottle plunger was not broken.The catheter/tube was not replaced but was cut, made shorter and added a replacement valve.The patient was successfully treated without harm.
Additional Manufacturer Narrative
H11: this supplemental mdr is being submitted to correct date of awareness to 18-feb-2026 since it was identified this was the date the legal manufacturer learned this event was an mdr reportable event, fda report number.D4 (medical device catalog #) 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 the pleurx drainage kit plunger was defective.No patient harm was reported.During follow up response it was further reported that the drain valve broke.No patient impact was reported.Additional follow up received by the customer stated the piece connected to the catheter that is inserted in the patient's lung is the component that broke and that the bottle plunger was not broken.The catheter/tube was not replaced but was cut, made shorter and added a replacement valve.The patient was successfully treated without harm.

• Brand Name: UNKNOWN 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: 24599380
• Report Number: 1423507-2026-00044
• Device Sequence Number: 9507062
• Product Code: DWM
• UDI-Device Identifier: 10885403090714
• UDI-Public: (01)10885403090714
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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: Lay User/Patient
• Device Catalogue Number: UNKNOWN PLEURX
• 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: 03/02/2026
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 03/18/2026
• 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