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

Catalog Number	50-9050A
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
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.One photo was provided; photo review is currently underway.The device was not returned for evaluation.The investigation is currently underway.Upon completion of the investigation, a supplemental report will be filed.D4 (expiration date is unknown), 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.
Event or Problem Description
It was reported that on (b)(6) 2025, the peritx peritoneal catheter mini kit valve was damaged by the patient.The issue was resolved by changing the valve.Successful drainage was achieved.No medical intervention was reported.No exposure to blood / bodily fluid was reported.No patient injury was reported.
Additional Manufacturer Narrative
H11: a physical sample was not received by our quality team for evaluation.One photo was provided for analysis and reviewed.During photo review, the valve is obscured by unidentified components.As a result, no additional observations could be made, and a cause related to the reported failure could not be determined from the photo alone.Note: the entry description states that the ¿.Valve was damaged by the patient.¿ based on this information, the damage may be due to user error.The complaint will be entered into the complaint management system, where it will be tracked, trended, and included in ongoing quality data analysis for future review and investigation.A review of the device history record (dhr) for part: 50-9050a lot: 0001592926 was conducted.No confirmed quality issues or rejections related to the reported incident were identified.The review verified that all procedural and functional criteria required for product release were fully satisfied.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).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, the peritx peritoneal catheter mini kit valve was damaged by the patient.The issue was resolved by changing the valve.Successful drainage was achieved.No medical intervention was reported.No exposure to blood / bodily fluid was reported.No patient injury was reported.

• Brand Name: PERITX
• 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: 23970717
• Report Number: 1423507-2026-00004
• Device Sequence Number: 21522008
• Product Code: PNG
• UDI-Device Identifier: 10885403500831
• UDI-Public: (01)10885403500831(10)0001592926
• 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): 02/19/2026

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: 0001592926
• 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: 12/08/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown