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

Catalog Number	50-9050A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the valve was leaking during use.The issue was resolved by replacing the valve, after which successful drainage was achieved.There was no patient injury, no medical intervention required, and no impact on the patient or course of treatment.The safety valve was noted to be damaged.The procedure was performed by an ewimed employee at the patient¿s home, with the catheter placed in the ascites position since (b)(6) 2025.
Additional Manufacturer Narrative
H11: a lot number was provided so a device history record is currently underway.Photos were provided and review is currently pending.H3 (device eval by manufacturer) a device has not been returned.Upon completion of the investigation, a supplemental report will be filed.G4: pma/510(k): 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.

• Brand Name: PERITX PERITONEAL CATHETER MINI KIT
• Common Device Name: PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING
• 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 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 25412809
• Report Number: 1423507-2026-00081
• Device Sequence Number: 6000572
• Product Code: PNG
• UDI-Device Identifier: 10885403500831
• UDI-Public: (01)10885403500831(17)270331(10)0001553138
• 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
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2026

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: 50-9050A
• Device Lot Number: 0001553138
• 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: 05/19/2026
• Supplement Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 06/05/2026
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown