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	01/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr 11414338 initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a0401.Patient problem code: f26.H10: as the lot number for the device was not provided, a review of the device history records has not been performed.The device was not returned.The investigation is currently underway.H11: 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
Injury (patient / other): no.Product possible involved in injury: no.Product available for inquiry: no.Location: 2 - when using.Origin: patient.Complaint: insertion pin of the drainage system cannot be inserted into the catheter valve.Additional informations: description of issue (what / why): insertion pin of the drainage system cannot be inserted into the catheter valve.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: 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: (b)(6) 2024.Connected device (pleurx/peritx/brand) 50-9050a.Procedure performed by: nurse.Procedure performed at: hospital.Replacement requested: no.Credit requested: yes.Additional information: information on the error pattern: fault location: valve.Error type: damaged (broken, brittle, deformed).
Event or Problem Description
Input type: oral.Injury (patient / other): no.Product possible involved in injury: no.Product available for inquiry: no.Location: 2 - when using.Origin: patient.Complaint: insertion pin of the drainage system cannot be inserted into the catheter valve.Additional informations: description of issue (what / why): insertion pin of the drainage system cannot be inserted into the catheter valve.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: 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: (b)(6) 2024.Connected device (pleurx/peritx/brand) 50-9050a procedure performed by: nurse procedure performed at: hospital replacement requested: no credit requested: yes additional information: information on the error pattern: fault location: valve.Error type: damaged (broken, brittle, deformed).
Additional Manufacturer Narrative
H10: manufacturing review: a probable root cause for this reported failure mode could not be determined, there was not enough information to fully investigate this incident as a lot number, photos or physical samples were unavailable for analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.This complaint will be entered into the complaint management system and will be tracked and trended for future occurrences.H11: 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 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: 21223524
• Report Number: 1625685-2025-00005
• Device Sequence Number: 8786348
• 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): 02/12/2025

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: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 02/12/2025
• 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
• Patient Sex: Unknown