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	10/29/2024
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 device possibly involved in injury: no device available for examination: yes; yes location: 2 - during application origin: relative complaint: valve leaking.Additional information: description of issue (what / why): valve leaking how often occurred 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 broke/damaged: no locking tab broke/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: 06.09.2024 connected device (pleurx/peritx/brand) 50-9050a procedure performed by: ewimed employee procedure performed at: home replacement requested: no credit requested: yes closure letter needed: yes additional information: information on the error: error location: valve error type: leaking response received: 22-nov-2024 as per provided information -"safety valve broken / damaged / disconnected: yes" could you please confirm was the valve cracked or broken? - yes could you please confirm was the catheter valve disconnected from the catheter? - yes if yes, was the clamp open when valve disconnected from the catheter? - no is there a photo or sample available showing the reported issue? - no.
Additional Manufacturer Narrative
H10: correction in investigation exec summary: one valve was provided to our quality team for investigation.Through visual inspection, it was observed that the internal valves were pulled out of alignment and pushed through the valve.The cause of the defect is unknown.A device history record could not be evaluated as the lot number is unknown.Based on the available information we are not able to identify a root cause at this time.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.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, device possibly involved in injury: no, device available for examination: yes; yes, location: 2 - during application, origin: relative, complaint: valve leaking.Additional information: description of issue (what / why): valve leaking, how often occurred 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 broke/damaged: no, locking tab broke/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: ewimed employee, procedure performed at: home, replacement requested: no, credit requested: yes, closure letter needed: yes.Additional information: information on the error: error location: valve, error type: leaking.Response received: 22-nov-2024 as per provided information -"safety valve broken / damaged / disconnected: yes" could you please confirm was the valve cracked or broken? - yes could you please confirm was the catheter valve disconnected from the catheter? - yes if yes, was the clamp open when valve disconnected from the catheter? - no is there a photo or sample available showing the reported issue? - no,.
Event or Problem Description
Injury (patient / other): no device possibly involved in injury: no device available for examination: yes; yes location: 2 - during application origin: relative complaint: valve leaking additional information: description of issue (what / why): valve leaking how often occurred 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 broke/damaged: no locking tab broke/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: 06.09.2024 connected device (pleurx/peritx/brand) 50-9050a procedure performed by: ewimed employee procedure performed at: home replacement requested: no credit requested: yes closure letter needed: yes additional information: information on the error: error location: valve error type: leaking response received: (b)(6) 2024 as per provided information -"safety valve broken / damaged / disconnected: yes" could you please confirm was the valve cracked or broken? - yes could you please confirm was the catheter valve disconnected from the catheter? - yes if yes, was the clamp open when valve disconnected from the catheter? - no is there a photo or sample available showing the reported issue? - no.
Additional Manufacturer Narrative
H10: one valve was provided to our quality team for investigation.Through visual inspection, it was observed that the internal valves were pulled out of alignment and pushed through the valve.The cause of the defect is unknown.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.Although we can confirm a failure with internal valve placement, we are unable to determine when the failure occurred.A device history record could not be evaluated as the lot number is unknown.Based on the available information we are not able to identify a root cause at this time.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.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: 20759030
• Report Number: 1625685-2024-00128
• Device Sequence Number: 9356227
• 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,Followup
• Report Date (Section B): 01/27/2025

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 01/27/2025; 01/27/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 01/27/2025; 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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