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	07/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a0401.Patient problem code: f26.
Event or Problem Description
Injury (patient / other): no, device possibly involved in injury: no.Complaint: valve leaking product information: article no: 50-9050a/v001 - peritx¿ ascites catheter additionally affected article no: 50-9050a/v001 - peritx¿ ascites catheter.Additional information: description of issue (what / why): valve leaking, how often occured defect: once, medical intervention (other than first aid): nein, needle/probe stick: nein, other actions taken: nein, safety issue: nein, issue resolved: ja.How issue resolved / additional information: valve change photo / sample available: ja, safety valve broken / damaged / disconnected: ja, safety clamp open, when valve broke/damaged/disconnected: nein, safety valve nose broken / damaged: nein, locking tab broken / damaged: nein, leakage: ja, successful drainage: ja.Impact to patient: no impact to patient.Exposure to blood / bodily fluid: nein.Course of treatment changed due to event: nein.Time catheter in place: on (b)(6) 2021.Connected device (pleurx/peritx/brand) 50-9050a.Procedure performed by: ewimed employee.Procedure performed at: home.Replacement requested: nein.Credit requested: ja.Additional information: information on the fault pattern: fault location: valve type of fault: leaking.
Event or Problem Description
Injury (patient / other): no, device possibly involved in injury: no, device available for examination: yes, detection site: 2 - on application, origin: patient, complaint: valve leaking, product information: additional information: description of issue (what / why): valve leaking, how often occured defect: once, medical intervention (other than first aid): no, needle/probe stick: no, other actions taken: no, safety issue: nein, issue resolved: yes, how issue resolved / additional information: valve change, photo / sample available: ja, safety valve broken / damaged / disconnected: yes, safety clamp open, when valve broke/damaged/disconnected: no, safety valve nose broken / damaged: no, locking tab broken / damaged: no, leakage: yes, successful drainage: yes, impact to patient: no impact to patient, exposure to blood / bodily fluid: no, course of treatment changed due to event: no, time catheter in place: on (b)(6) 2021, connected device (pleurx/peritx/brand) 50-9050a, procedure performed by: (b)(6) employee, procedure performed at: home, replacement requested: nein, credit requested: ja, additional information: information on the fault pattern: fault location: valve, type of fault: leaking.
Additional Manufacturer Narrative
(b)(4).Follow-up emdr for device evaluation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified, and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.We would be very interested in examining product that does 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 affected device.Examination of the product involved may provide clarification as to the cause for the reported failure.We regret any inconveniences this incident may have caused you and your facility.Complaints received for this product and condition 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.

• Brand Name: PERITX PERITONEAL CATHETER MINI KIT
• Common Device Name: PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 19914721
• Report Number: 1625685-2024-00093
• Device Sequence Number: 12663043
• Product Code: PNG
• UDI-Device Identifier: 10885403500831
• UDI-Public: (01)10885403500831
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K201155
• 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): 09/10/2024

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: Other
• Device Catalogue Number: 50-9050A
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown