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	08/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, the pleurx pleural catheter mini kit safety valve broken / damaged / disconnected causing a valve leakage.The issue was resolved by changing the valve.The patient was successfully drained and there was no impact to the patient.
Additional Manufacturer Narrative
H11: the lot number for the device was provided.Photos have not yet been received.The device history records are currently under review.The investigation is currently underway.H3 (device eval by manufacturer) a 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 on (b)(6) 2025, the pleurx pleural catheter mini kit safety valve broken / damaged / disconnected causing a valve leakage.The issue was resolved by changing the valve.The patient was successfully drained and there was no impact to the patient.
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 review of the internal manufacturing device records and raw material history files for the reported lot number 0001538088 was performed and no recorded quality problems or rejections related to this incident were found.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.Based on the available information we are not able to identify a root cause at this time.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.D3 (medical device manufacturer), g3 (date received by manufacturer), g6 type or report - follow up# 1), h2 (correction and additional information), 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.

• 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: 22946258
• Report Number: 1625685-2025-00082
• Device Sequence Number: 18429623
• Product Code: DWM
• UDI-Device Identifier: 10885403075988
• UDI-Public: (01)10885403075988(17)270331(10)0001538088
• 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: 0001538088
• 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: 08/12/2025
• 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
• Date Device Manufactured: 10/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown