MAUDE Adverse Event Report: CAREFUSION, INC PLEURX DRAINAGE KIT 1000ML; APPARATUS, SUCTION, PATIENT CARE

Catalog Number	50-7510
Medical Device Problem Code	Device Contaminated at the User Facility (4064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: the lot number for the device was provided.The device history records are currently under review.A photo was provided and review is underway.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.D2b: procode: dwm; png g4: pma / 510(k)#: k160437; k160450; k201155; k241946.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 an attempt to use the pleurx drainage kit by end user / lay person at home, the bottle was found contaminated as it appeared to already have been used.The issue was resolved by replacing the bottle with a new one.The patient was successfully drained, and no patient injury was reported.It was further reported that the patient was not exposure to blood / bodily fluid.
Event or Problem Description
It was reported that during an attempt to use the pleurx drainage kit by end user/lay person at home, the bottle was found contaminated as it appeared to already have been used.The issue was resolved by replacing the bottle with a new one.The patient was successfully drained, and no patient injury was reported.It was further reported that the patient was not exposure to blood/bodily fluid.
Additional Manufacturer Narrative
H11: the physical sample was not received for evaluation.One photo was provided for review.During the photo review process, the image provided by the customer showed a slight reddish/whitish discoloration inside the drainage tubing, which is consistent with bodily fluids (blood mixed with lipids or proteins) and can occur during the initial pleural drainage process or due to the patient¿s condition and diet.No solid particles or signs of external contamination were identified.The investigation is inconclusive as the reported condition does not indicate product contamination or a manufacturing defect.A probable root cause could not be established based on the provided information.A review of the internal manufacturing device record and raw material history files for the reported lot number 0001606058 was performed and no recorded quality problems or rejections related to this incident were found.It was confirmed that procedural and functional requirements needed for its release were met.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.D2b: procode: dwm; png, g3 (date received by manufacturer), g4: pma/510(k)#: k160437; k160450; k201155; k241946, 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.

• Brand Name: PLEURX DRAINAGE KIT 1000ML
• 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; zona franca las americas; santo domingo
• Manufacturer Contact: brett curtice_ ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 23280741
• Report Number: 1423507-2025-00097
• Device Sequence Number: 8809444
• Product Code: DWM
• UDI-Device Identifier: 10885403090707
• UDI-Public: (01)10885403090707(17)270709(10)0001606058
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: SEE H.11.
• 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): 12/29/2025

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: Lay User/Patient
• Device Catalogue Number: 50-7510
• Device Lot Number: 0001606058
• 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: 09/18/2025
• Supplement Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown