MAUDE Adverse Event Report: CAREFUSION, INC PLEURX PLEURAL CATHETER KIT; APPARATUS, SUCTION, PATIENT CARE

Catalog Number	50-7000B
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
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.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 by customer that the chloroprep swab was leaking at the seal.A second procedure tray had to be obtained from the stock room.During follow up response it was further reported that the chloraprep was unopened at the time the leak was discovered.No visual damage was observed upon receipt of the product.There was no patient exposure or harm reported.The issue was detected prior to use.
Additional Manufacturer Narrative
H11: five photo samples were provided to our quality team for investigation.Upon visual inspection of the photos, we can confirm that broken pieces of the lidocaine vials are present.We can also confirm that component containing the orange dye was at minimum activated.However, we cannot confirm whether the inner chloraprep vials were broken or if the component containing the dye activated as a result of the broken lidocaine vials, and exposure to the liquid/lidocaine.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001614536 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.Sterilization review indicates no damage was reported for the shipment.Based on the available information we are not able to identify a root cause at this time.Distribution center will be notified in an effort to raise awareness.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 by customer that the chloroprep swab was leaking at the seal.A second procedure tray had to be obtained from the stock room.During follow up response it was further reported that the chloraprep was unopened at the time the leak was discovered.No visual damage was observed upon receipt of the product.There was no patient exposure or harm reported.The issue was detected prior to use.

• Brand Name: PLEURX PLEURAL CATHETER 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: 24185154
• Report Number: 1423507-2026-00011
• Device Sequence Number: 21245067
• Product Code: DWM
• UDI-Device Identifier: 10885403075971
• UDI-Public: (01)10885403075971(17)270331(10)0001614536
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K160450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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: 50-7000B
• Device Lot Number: 0001614536
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown