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

Catalog Number	50-9050A
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
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.The device has not been returned.Photos were not provided.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, the valve was damaged by other unknown material, and the safety valve was found broken / damaged / disconnected.The valve was changed to resolve the issue and drainage was successful.There were no medical intervention and there was no exposure to blood/bodily fluid.No impact to the patient was reported.During follow up response it was further reported that an unknown material was connected by force, but it is unclear what material components were connected by force.It was clarified that the valve was cracked but it is unknown if the valve disconnected.The patient is being treated for ascites.
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.However, a potential cause of the failure could be contributed to use error, as per the entry description "during follow up response it was further reported that an unknown material was connected by force, but it is unclear what material components were connected by force." a review of the device history record (dhr) for part: 50-9050a lot: 0001591651 was conducted.No confirmed quality issues or rejections related to the reported incident were identified.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.Complaints received for 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 the identification of emerging trends.D4 (medical device expiration date), g3 (date received by manufacturer), g6 type or report - follow up# 1), h2 (correction and additional information), annex a (medical device problem code), 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, during use of the peritx peritoneal catheter mini kit, the valve was damaged by other unknown material, and the safety valve was found broken / damaged / disconnected.The valve was changed to resolve the issue and drainage was successful.There were no medical intervention and there was no exposure to blood/bodily fluid.No impact to the patient was reported.During follow up response it was further reported that an unknown material was connected by force, but it is unclear what material components were connected by force.It was clarified that the valve was cracked but it is unknown if the valve disconnected.The patient is being treated for ascites.

• 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: 23420412
• Report Number: 1423507-2025-00119
• Device Sequence Number: 9571465
• Product Code: PNG
• UDI-Device Identifier: 10885403500831
• UDI-Public: (01)10885403500831(10)0001591651
• 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): 01/14/2026

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: 0001591651
• 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: 10/08/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown