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	08/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: the lot number was not provided; a review of the device history records has not been performed.Photos were not provided for review.The device has not been returned.Upon completion of the investigation, a supplemental report will be filed.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.The valve was changed, and issue was resolved.There was no reported patient injury.
Additional Manufacturer Narrative
H11: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified, and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.Product undergoes inspections during manufacturing, no issues related to the reported incident were identified, all procedural and functional requirements for product release have been met.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.B5 (describe event or problem), d3 (medical device manufacturer), d4 (expiration date is unknown), g3 (date received by manufacturer), g6 type or report - follow up# 1), h2 (correction and additional information), h4 (device manufacturing date is unknown), h6 (annex g ¿ component code), annex b (type of investigation), annex c (investigation findings), annex d (investigation conclusions).Initial mdr mfr report # 1625685-2025-00077, site legal name (fda) reported, carefusion 2200, inc.- mannford, ok / 74044; site registration number (fda) (b)(4).Correct site legal name (fda) is, vernon hills; site registration number (fda) (b)(4).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 leakage.The valve was changed, and issue was resolved.There was no medical intervention and there was no exposure to blood / bodily fluid.Drainage was successful.There was no reported patient injury.During follow up response it was confirmed the valve was leaking.The valve did not disconnect on the catheter.The device was placed in the pleura.

• 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: 22947894
• Report Number: 1625685-2025-00083
• Device Sequence Number: 9137726
• 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): 11/18/2025

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: 08/13/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 12/02/2025
• 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