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

Catalog Number	50-9050A
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2025
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.Photos have not been submitted for review.The device is not available for return.The investigation is currently underway.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.
Event or Problem Description
It was reported that on (b)(6) 2025 during use of the peritx peritoneal catheter mini kit a hole in the tube behind the valve was identified causing leakage.The valve was changed to resolve the issue and drainage was successful.The patient was not exposure to blood/bodily fluid and there was no medical intervention.No patient injury was reported.
Event or Problem Description
It was reported that on (b)(6) 2025 during use of the peritx peritoneal catheter mini kit a hole in the tube behind the valve was identified causing leakage.The valve was changed to resolve the issue and drainage was successful.The patient was not exposure to blood/bodily fluid and there was no medical intervention.No patient injury was reported.During follow up response it was further reported that the tube was shortened, and a new valve was fitted.
Additional Manufacturer Narrative
H11: there were no photos provided for review and the physical sample was not received by our quality team for evaluation therefore the failure mode could not be verified, and the root cause could not be determined.A review of the internal manufacturing device record and raw material history files for the reported lot number was performed and no recorded quality problems or rejections related to this incident were found.It was confirmed that procedural and functional requirements needed for its release were met.We would be very interested in examining products that do not meet your expectations and our quality standards.A photo of the defect could assist our quality team in their investigation.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis of the device affected.Examination of the product involved may provide clarification as to the cause of the reported failure.We regret any inconvenience this incident may have caused you and your facility.Complaints received about this product and conditions will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.B5 (describe event or problem), 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.

• 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: 23373338
• Report Number: 1423507-2025-00113
• Device Sequence Number: 18672502
• Product Code: PNG
• UDI-Device Identifier: 10885403500831
• UDI-Public: (01)10885403500831(17)261130(10)0001523336
• 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): 01/05/2026

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: 0001523336
• 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: 10/01/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown