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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
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: a050401.Patient problem code: f26.
Event or Problem Description
Injury (patient / other): no.Product possible involved in injury: no.Product available for inquiry: yes.Complaint: valve leaking liquid leaking out.Additional informations: 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: no.Issue resolved: yes how issue resolved / additional information: valve change.Photo / sample available: no.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: no.Successful drainage: yes.Impact to patient: no indication for that / not applicable.Exposure to blood / bodily fluid: no.Course of treatment changed due to event: no.Time catheter in place: (b)(6) 2024 connected device (pleurx/peritx/brand) 50-9050a.Procedure performed by: (b)(6).Procedure performed at: home.Replacement requested: no.Credit requested: and.Closure letter needed: yes.Additional information: information on the error pattern: fault location: valve.Error type: leaky.Response received on (b)(6) 2024.- was there any damage noticed on catheter valve? ¿ not known.- was the valve cracked or broken? ¿ not known.- was the valve disconnected from the catheter? ¿ not known.- if yes, was the clamp open when valve disconnected from the catheter? ¿ not known.- where is the catheter located? abdomen or chest - abdomen.- did the patient require additional diagnostics other than the valve replacement to be able to drain.-no.- what was the impact to the patient? - has already been given.- could you please provide a date of event? - has already been given.- could you please provide the lot number of the defective product? - has already been given.
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.
Event or Problem Description
Injury (patient / other): no product possible involved in injury: no product available for inquiry: yes location: 2 - when using origin: member complaint: valve leaking liquid leaking out product: item no.: 50-9050a/v001 - peritx¿ gassing-catheter additionally affected article no.: 50-9050a/v001 - peritx¿ gassing-catheter additional informations: 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: no issue resolved: yes how issue resolved / additional information: valve change photo / sample available: no 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: no successful drainage: yes impact to patient: no indication for that / not applicable exposure to blood / bodily fluid: no course of treatment changed due to event: no time catheter in place: 31.05.2024 connected device (pleurx/peritx/brand) 50-9050a procedure performed by: ewimed employee procedure performed at: home replacement requested: no credit requested: and closure letter needed: yes additional information: information on the error pattern: fault location: valve error type: leaky response received on 23-oct-2024 - was there any damage noticed on catheter valve? ¿ not known - was the valve cracked or broken? ¿ not known - was the valve disconnected from the catheter? ¿ not known - if yes, was the clamp open when valve disconnected from the catheter? ¿ not known - where is the catheter located? abdomen or chest - abdomen - did the patient require additional diagnostics other than the valve replacement to be able to drain.-no - what was the impact to the patient? - has already been given - could you please provide a date of event? - has already been given - could you please provide the lot number of the defective product? - has already been given.

• 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: brett curtice ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 20516247
• Report Number: 1625685-2024-00115
• Device Sequence Number: 8559436
• 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): 11/08/2024

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: 10/17/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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