MAUDE Adverse Event Report: CAREFUSION, INC PLEURX; PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING

Catalog Number	50-7050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	08/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: a lot number was provided; the device history records are currently under review.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.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 through the results of the clinical trial ((b)(4) (arch) of a non-commercially available device (bd liverty tips stent graft study).During use of a pleurx catheter product and since insertion of the pleurx the subject experienced severe lower abdominal pain, increased abdominal girth, water retention in legs and scrotum.It was reported that the pleurx drain catheter was alleged to have infection.The severity of the adverse event was mild.The outcome of the adverse event was not resolved/recovered.The adverse event was led to hospitalization, though it was not life-threatening, did not result in permanent impairment, and did not require medical or surgical intervention.
Event or Problem Description
It was reported through the results of the clinical trial (bdpi-20-004 (arch) of a non-commercially available device (bd liverty tips stent graft study).During use of a pleurx catheter product and since insertion of the pleurx the subject experienced severe lower abdominal pain, increased abdominal girth, water retention in legs and scrotum.It was reported that the pleurx drain catheter was alleged to have infection.The severity of the adverse event was mild.The outcome of the adverse event was not resolved/recovered.The adverse event was led to hospitalization, though it was not life-threatening, did not result in permanent impairment, and did not require medical or surgical intervention.It was further reported that the infection began on day 3 following the insertion of the pleurx catheter, which was implanted on (b)(6) 2025.The infection was first identified and officially recorded as an event on (b)(6) 2025.The catheter was located in the abdomen, and no photos were available for review.The issue was resolved on (b)(6) 2025 through the implantation of a new pleurx catheter.
Additional Manufacturer Narrative
H11: b5 (describe event or problem), h6: annex f, d2 (medical device type), d2 (common device name), g3 (date received by manufacturer).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.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001582245 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.The sterilization record was reviewed and found to be compliant, with no deviations or evidence of material damage documented.The reported infection could not be confirmed, and no root cause was identified.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.D3 (medical device manufacturer), b5 (describe event or problem), g3 (date received by manufacturer), g6 type or report - follow up# 2), h2 (correction and additional information), h6: annex g (component code), annex b (type of investigation), annex c (investigation findings), annex d (investigation conclusions), h4: device manufacturing date.Initial mdr mfr report, site legal name (fda) reported, carefusion 2200, inc.- mannford, ok / 74044; site registration number (fda) 1625685.Correct site legal name (fda) is, vernon hills; site registration number (fda) 1423507.H11: 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 through the results of the clinical trial (bdpi-20-004 (arch)) of a non-commercially available device (bd liverty tips stent graft study), that a subject experienced an adverse event following the use of a commercially available pleurx catheter, which was not part of the study.The pleurx catheter was implanted on (b)(6) 2025.The catheter was located in the left lower abdomen.On day 3 post-implantation ((b)(6)2025), the subject developed signs of infection, including severe lower abdominal pain, increased abdominal girth, and water retention in the legs and scrotum.The catheter was explanted on (b)(6) 2025.The severity of the adverse event was mild.The adverse event was not related to the study device.The adverse event was not related to the study procedure.The outcome of the adverse event was resolved/recovered following implantation of a new pleurx catheter on (b)(6) 2025.No photos were available for review.

• Brand Name: PLEURX
• Common Device Name: PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• 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: 23017418
• Report Number: 1625685-2025-00086
• Device Sequence Number: 9512174
• Product Code: DWM
• UDI-Device Identifier: 10885403075988
• UDI-Public: (01)10885403075988(17)290131(10)0001582245
• 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: Other,Study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 50-7050
• Device Lot Number: 0001582245
• 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: 08/20/2025
• Supplement Date Received by Manufacturer: 09/11/2025; 11/11/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 09/17/2025; 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Male