MAUDE Adverse Event Report: CAREFUSION, INC PERITX PERITONEAL CATHETER MINI KIT; APPARATUS, SUCTION, PATIENT CARE

Catalog Number	50-9050A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
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.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.Complaint: valve leaking.Product: 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: 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) 2023.Connected device (pleurx/peritx/brand): 50-9050a.Procedure performed by: (b)(6) employee.Procedure performed at: hospital.Replacement requested: no.Credit requested: yes.Closure letter needed: yes.Information on the error pattern: fault location: valve.Error type: leaky.Response received on 14-nov-2024: not known.Was the device being used in/on patient when the issue occurred? yes.Was patient or user harmed? if yes, please explain.No.Was the hcp present when the issue occurred? yes.If leakage occurred, please confirm the fluid that leaked.Effusion.Was additional medical intervention/medication required? if yes, please explain.No.Response received on 22-nov-2024: as per event description "safety valve broken / damaged / disconnected: yes".Was there any damage noticed on catheter valve? yes.Was the valve cracked or broken? not known.Was the valve disconnected from the catheter? yes.If yes, was the clamp open when valve disconnected from the catheter? no.Lot number associated with reported issue.Has already been reported.Date of the event- has already been reported.Where is the catheter located? abdomen or chest.Pleura.
Additional Manufacturer Narrative
H10: a lot was unavailable.A dhr review could not be performed.A sample was unavailable for analysis.We are unable to confirm the reported failure, a root cause could not be identified.Without additional information, we are unable to investigate further.The complaint will be entered into the complaint management system and will be tracked & trended for future occurrences and reviewed/investigated through the quality data analysis (qda) process.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
Njury (patient / other): no product possible involved in injury: no product available for inquiry: no location: 2 - when using origin: patient complaint: valve leaking.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: 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) 2023 connected device (pleurx/peritx/brand) 50-9050a procedure performed by: (b)(6) employee procedure performed at: hospital replacement requested: no credit requested: yes closure letter needed: yes information on the error pattern: fault location: valve error type: leaky response received on 14-nov-2024 not known ¿ was the device being used in/on patient when the issue occurred? - yes ¿ was patient or user harmed? if yes, please explain - no ¿ was the hcp present when the issue occurred? - yes ¿ if leakage occurred, please confirm the fluid that leaked.- effusion ¿ was additional medical intervention/medication required? if yes, please explain - no response received on 22-nov-2024 -as per event description "safety valve broken / damaged / disconnected: yes" - was there any damage noticed on catheter valve? - yes - was the valve cracked or broken? - not known - was the valve disconnected from the catheter - yes - if yes, was the clamp open when valve disconnected from the catheter? - no - lot number associated with reported issue.- has already been reported - date of the event- has already been reported - where is the catheter located? abdomen or chest- pleura.

• Brand Name: PERITX PERITONEAL CATHETER MINI KIT
• Common Device Name: APPARATUS, SUCTION, PATIENT CARE
• 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: 20761269
• Report Number: 1625685-2024-00127
• Device Sequence Number: 9356303
• Product Code: DWM
• UDI-Device Identifier: 10885403500831
• UDI-Public: (01)10885403500831
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

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: 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: 11/13/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 12/10/2024
• 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