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

Catalog Number	50-7050
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the lot number for the device was not provided, a review of the device history records has not been performed.Photos were provided; photo review is currently underway.The device is not available for 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.
Event or Problem Description
It was reported that on (b)(6) 2025, a hole in the pleurx tube behind the valve was caused by the patient while using a sharp object.The issue was resolved by changing the valve and drainage was successful.The patient was not exposure to blood/bodily fluid and there was no medical intervention.No harm to the patient was reported.During follow up response it was further reported that the hole was behind the valve, the hose was cut off with the valve, and a new valve was fitted.The tube was cut to remove the hole.
Additional Manufacturer Narrative
H11: a physical sample was not returned for evaluation.Two photos were provided for analysis.The reported failure was for a pleurx code (50-7050).The valve in photo 2 is labeled as peritx.The pleurx valve is associated with 50-7050 pleurx code and the peritx valve is associated with the 50-9050a peritx code.In addition, the catheter placed in the low abdominal space which is proper placement for the peritx catheter.With regard to the reported failure ¿during follow up response it was further reported that the hole was behind the valve.¿ we cannot definitively confirm the presence of a hole given the provided photos.Given the information provided within the entry description "it was reported that on (b)(6) 2025, a hole in the pleurx tube behind the valve was caused by the patient while using a sharp object." we can confirm that the potential cause of the hole on/in the catheter tubing is use related.A device history record (dhr) review could not be performed as the lot number is unknown.The complaint was entered into the complaint management system and will be tracked & trended for future occurrences and reviewed/investigated through the quality data analysis process.D4 (expiration date is unknown), g3 (date received by manufacturer), g6 type or report - follow up# 1), h2 (correction and additional information), h4 (device manufacturing date is unknown), 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, a hole in the pleurx tube behind the valve was caused by the patient while using a sharp object.The issue was resolved by changing the valve and drainage was successful.The patient was not exposure to blood/bodily fluid and there was no medical intervention.No harm to the patient was reported.During follow up response it was further reported that the hole was behind the valve, the hose was cut off with the valve, and a new valve was fitted.The tube was cut to remove the hole.

• Brand Name: PLEURX
• 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 north fairway drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 23373533
• Report Number: 1423507-2025-00114
• Device Sequence Number: 21315257
• Product Code: DWM
• UDI-Device Identifier: 10885403075988
• UDI-Public: (01)10885403075988
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160450
• 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): 01/27/2026

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: 50-7050
• Device Lot Number: UNKNOWN
• 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: 10/02/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown