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

Catalog Number	50-9050A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	12/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: a physical sample was received from our quality team and evaluated.During visual inspection, one catheter was returned.It was verified that the catheter was used.However, we were unable to observe any anomalies that would have contributed to the reported failure.A lot was not available; therefore, a dhr review could not be performed since without a specific lot number, a review of sterility records, manufacturing history, and supplier documentation could not be performed.These records are essential for determining whether any deviations, nonconformances, or material issues could have contributed to the reported event.As a result, no conclusion regarding a potential root cause could be established.The complaint will be entered into the complaint management system and will be tracked & trended for future occurrences and reviewed/investigated through the quality data analysis process.D9 (device available for evaluation; received to manufacturer on), g3 (date received by manufacturer), g6 type or report - follow up# 1), h2 (correction, additional information, and device evaluation), h3 (device eval by manufacturer?), 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 patient came to the ugei with inflamed skin on the pathway looking like infectious dermohypodermatitis and the interventional radiology unit was concerned.
Additional Manufacturer Narrative
H11: the lot number was not provided; a review of the device history records could not be performed.Photos were not provided for review.The device has not been returned.Upon completion of the investigation, a supplemental report will be filed.D4.(medical device expiration date is unknown).G4: pma / 510(k)#: k201155; k241946.H4 (device manufacturing date is unknown).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 patient came to the ugei with inflamed skin on the pathway looking like infectious dermohypodermatitis and the interventional radiology unit was concerned.

• 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: 24084421
• Report Number: 1423507-2026-00005
• Device Sequence Number: 13182745
• Product Code: PNG
• UDI-Device Identifier: 10885403500831
• UDI-Public: (01)10885403500831
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: SEE H.11.
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2026

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: 50-9050A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown