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

Catalog Number	50-7510
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, the pleurx drainage kit dressing was not intact/sterile.No patient harm was reported.
Additional Manufacturer Narrative
H11: the lot number for the device was provided.The device history records are currently under review.The device has not been returned for evaluation, and photos have not been provided for review.The investigation is currently underway.Upon completion of the investigation, a supplemental report will be filed.D2b: pro code: 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.
Additional Manufacturer Narrative
H11: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified, and the root cause could not be determined.A review of the internal manufacturing device record and raw material history files for the reported lot number 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.Product undergoes inspections during manufacturing, no issues related to the reported incident were identified.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, the pleurx drainage kit dressing was not intact/sterile.No patient harm was reported.

• 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: 24125930
• Report Number: 1423507-2026-00006
• Device Sequence Number: 21175070
• Product Code: DWM
• UDI-Device Identifier: 10885403090707
• UDI-Public: (01)10885403090707(17)271024(10)0001621732
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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: Lay User/Patient
• Device Catalogue Number: 50-7510
• Device Lot Number: 0001621732
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2025
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown