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	12/01/2025
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.Photo was provided and review is currently pending.H3 (device eval by manufacturer) a device has not been returned.Upon completion of the investigation, a supplemental report will be filed.D4: medical device expiration date: unknown.H4: 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 the customer that the pleurx pleural catheter valve broken off.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 customer was able to successfully complete the drainage.The catheter had been in place since on (b)(6) 2020.
Event or Problem Description
It was reported by the customer that the pleurx pleural catheter valve broken off.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 customer was able to successfully complete the drainage.The catheter had been in place since (b)(6) 2020.During follow up response it was further reported that the valve is not manufactured by our organization.As a result, the complaint is not applicable.
Additional Manufacturer Narrative
H11: one photo sample was received by our quality team for investigation.Upon visual inspection of the photo, we are confident that the catheter shown is not manufactured at the bd mannford site, nor does it appear to be a bd component.We are unable to confirm whether the valve is a bd component, as the single photo does not provide sufficient detail.We can confirm that the valve appears to be missing its top half; however, we cannot determine the cause of this condition or verify whether the valve is a bd-manufactured component.A device history review could not be completed as no batch number was provided.During follow up response it was further reported that the valve is not manufactured by bd.As a result, the complaint is not applicable.This supplemental mdr file# (b)(4) is being submitted to report file # (b)(4).Based on additional information received by the customer it was confirmed that the product is not a bd product; therefore, this file no longer qualifies as a complaint.Initial mdr report submitted on fda report number 1423507-2025-00175.B5 (describe event or problem), 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
• 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: 23789943
• Report Number: 1423507-2025-00175
• Device Sequence Number: 5522073
• 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): 02/13/2026

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: 12/02/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 02/18/2026
• 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