MAUDE Adverse Event Report: CAREFUSION, INC PLEURX PLEURAL CATHETER MINI KIT; 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	11/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: a lot number was provided so a device history record is currently underway.Photos were provided and review is currently pending.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, after insertion of the pleurx pleural catheter kit, the valve immediately started leaking.The line was not connected, and since it is a one-way valve, no leakage was expected.When the cap was attached, fluid continued to drip, soaking the patient¿s top.The leakage could not be stopped, and a stopper with tape had to be applied to allow drainage.The unit appeared to be faulty.During the follow-up response it was further reported that the catheter was located in the abdomen.The damage to the valve was noticed after the drain was inserted and the patient had started draining.There were no signs of cracks on the valve, possibly broken from the inside because it leaked, fluid was coming out directly from the valve, this happening without the drainage line and the bag connected.Once cap was connected, a few seconds later the fluid would start dripping.The issue was resolved by replacing the faulty unit, patient due for another insertion while the doctor temporarily taped the catheter with a stopper to allow fluid drainage until the new insertion.By the time the catheter was removed, it had been in place for 14 days, as removal was delayed because he said there is actually not much fluid to drain out.
Additional Manufacturer Narrative
H11: one photo and one video sample were provided to the quality team for investigation.Through visual inspection, we confirmed that the unit is leaking.The photo and video show an additional component that is not part of the bd provided tray.If drainage was performed using non approved components, they may have damaged or altered the internal valves, contributing to the failure.Because no physical sample is available for evaluation, the root cause cannot be confirmed at this time.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001594708 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.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).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, after insertion of the pleurx pleural catheter kit, the valve immediately started leaking.The line was not connected, and since it is a one-way valve, no leakage was expected.When the cap was attached, fluid continued to drip, soaking the patient¿s top.The leakage could not be stopped, and a stopper with tape had to be applied to allow drainage.The unit appeared to be faulty.During the follow-up response it was further reported that the catheter was located in the abdomen.The damage to the valve was noticed after the drain was inserted and the patient had started draining.There were no signs of cracks on the valve, possibly broken from the inside because it leaked, fluid was coming out directly from the valve, this happening without the drainage line and the bag connected.Once cap was connected, a few seconds later the fluid would start dripping.The issue was resolved by replacing the faulty unit, patient due for another insertion while the doctor temporarily taped the catheter with a stopper to allow fluid drainage until the new insertion.By the time the catheter was removed, it had been in place for 14 days, as removal was delayed because he said there is actually not much fluid to drain out.

• Brand Name: PLEURX PLEURAL CATHETER MINI KIT
• 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: 23622591
• Report Number: 1423507-2025-00152
• Device Sequence Number: 21095396
• Product Code: DWM
• UDI-Device Identifier: 10885403075988
• UDI-Public: (01)10885403075988(17)290228(10)0001594708
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K160450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 50-7050
• Device Lot Number: 0001594708
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown