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	08/28/2025
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.Photo review is under way.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.D2: procode: dwm; png.G4: 510k: k160437; k160450; k201155.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 the pleurx drainage kit was found to be contaminated and appeared to have already been used.Another device was used to drain the patient.There was no reported patient injury.
Additional Manufacturer Narrative
H11: the physical sample was not returned for evaluation which limited the ability to confirm whether the device was previously used.One photo image was received and reviewed.The photo showed a reddish-dark fluid inside the drainage tubing, with dense or cloudy areas that may suggest the presence of fat or blood clots.The fluid's appearance is consistent with blood or a mixture of bodily fluids.Based on the image, the fluid is located near the beginning of the tubing, suggesting that the customer had just started using the bottle at the time the photo was taken.The fluid observed appeared to be blood with clots or accumulated fat, which is a normal characteristic of bodily fluids and cannot be confirmed as a foreign particle.The presence of fluid in the tubing does not necessarily indicate prior use, as it may have occurred during the initial drainage process.Based on the image evaluation and the absence of a returned sample, the reported failure mode cannot be confirmed.The fluid characteristics observed are consistent with expected drainage contents and do not provide sufficient evidence of contamination or prior use.Based on the investigation performed, a probable root cause could not be established during the analysis performed with the information available as no issues were found.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.D3 (medical device manufacturer), 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).G4: pma / 510(k)#: k160437; k160450; k201155; k241946.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 the pleurx drainage kit was found to be contaminated and appeared to have already been used.Another device was used to drain the patient.There was no reported patient injury.

• 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: 23083623
• Report Number: 9680904-2025-00027
• Device Sequence Number: 21266899
• Product Code: DWM
• UDI-Device Identifier: 10885403090707
• UDI-Public: (01)10885403090707(17)270706(10)0001605769
• 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): 10/10/2025

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: Health Professional
• Device Catalogue Number: 50-7510
• Device Lot Number: 0001605769
• 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: 08/28/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown