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

Catalog Number	50-7510
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025 before use of the pleurx drainage kit, a yellow substance was observed on the outside and inside of the packaging.There was no reported impact to the patient.
Additional Manufacturer Narrative
H11: the lot number for the device was provided.The device history records are currently under review.Photos have not been provided for review.The device is pending return.The investigation is currently underway.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.
Additional Manufacturer Narrative
H11: two pleurx kits, reference 50-7510, were received for evaluation.The packaging label confirmed that the code 50-7510 and lot number 0001606055 matched the reported product.Both kits exhibited yellow stains across the pouch surface and partially on the label.These stains were widespread and visible, suggesting potential contamination or a packaging integrity issue.Visual inspection indicated that the discoloration was superficial.Although procedural and functional requirements for release were met, it remains unclear whether any procedural deficiencies contributed to the reported issue.A definite root cause could not be determined.A review of the internal manufacturing device records 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.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.D2b: procode: dwm; png, d3 (medical device manufacturer), d9 (device available for eval?; returned to manufacturer date), g3 (date received by manufacturer), g4: pma/510(k): k160437; k160450; k201155; k241946, h2 (correction, additional information, and device evaluation), h3 (device eval by manufacturer), annex b (type of investigation), annex c (investigation findings), annex d (investigation conclusions).Initial mdr mfr report # 9680904-2025-00027, site legal name (fda) reported, carefusion d.R.203 ltd.- santo domingo, dominican republic; site registration number (fda) 9680904.Correct site legal name (fda) is, vernon hills; site registration number (fda) 1423507.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 before use of the pleurx drainage kit, a yellow substance was observed on the outside and inside of the packaging.There was no reported impact to the patient.During follow up response it was further reported that the substance was described as a liquid that penetrated the sterile barrier and dried out, possibly iodine or a dye of some sort.

• 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: 22963495
• Report Number: 9680904-2025-00026
• Device Sequence Number: 8453522
• Product Code: DWM
• UDI-Device Identifier: 10885403090707
• UDI-Public: (01)10885403090707(17)270709(10)0001606055
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

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: 0001606055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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