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	10/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Injury (patient / other): no.Device possibly involved in injury: no.Device available for investigation: yes.Place where noticed: 2 - during use.Origin: patient.Complaint: valve defect 10 days after implantation without external influence and regular use.Additional information: description of the problem (what/why): valve defect.How often did the defect occur: once.Medical intervention (other than first aid): no.Needlestick/probe stick: no.Other measures: no.Safety issue: no.Problem resolved: yes.How was the problem resolved/additional information: valve change photo/sample available: yes.Safety valve broken/damaged/disconnected: yes.Safety clamp open when valve broke/damaged/disconnected: no.Safety valve nose broken/damaged: no.Safety tab broken/damaged: no.Leakage: yes.Successful drainage: yes.Patient impact: no impact on patient blood/body fluid contact: no.Treatment changed due to incident: no.Time of catheter insertion: on (b)(6) 2024.Device attached (pleurx/peritx/brand) 50-9050a.Performed by: ewimed employee.Performed in: home.Error description: error location: valve.Error type: damaged (broken, brittle, deformed).Additionally affected lot nos.: 0001534421.Response received: 19-nov-2024.Was there any damage noticed on catheter valve? not known.Was the valve cracked or broken? not known.Was there leakage noticed at the catheter valve? not known.Was the clamp open when valve disconnected from the catheter? no.If yes, was the clamp open when valve disconnected from the catheter? no.Where is the catheter located? abdomen or chest, abdomen.Is there a photo or sample available showing the reported issue? see in the first mail from us - sample available.Date of event - date received: 2024-10-22.
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.H10: d4 (expiration date: 01/2027).H10: the lot number for the device was provided.The device history records are currently under review.The device is pending return.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.Device possibly involved in injury: no.Device available for investigation: yes.Place where noticed: 2 - during use.Origin: patient.Complaint: valve defect 10 days after implantation without external influence and regular use.Additional information: description of the problem (what/why): valve defect how often did the defect occur: once medical intervention (other than first aid): no needlestick/probe stick: no other measures: no safety issue: no problem resolved: yes how was the problem resolved/additional information: valve change photo/sample available: yes safety valve broken/damaged/disconnected: yes safety clamp open when valve broke/damaged/disconnected: no safety valve nose broken/damaged: no safety tab broken/damaged: no leakage: yes successful drainage: yes patient impact: no impact on patient blood/body fluid contact: no treatment changed due to incident: no time of catheter insertion: 10/08/2024 device attached (pleurx/peritx/brand) 50-9050a performed by: ewimed employee performed in: home replacement requested: no credit memo requested: yes final letter required: yes additional information: error description: error location: valve error type: damaged (broken, brittle, deformed) additionally affected lot nos.: 0001534421 response received: 19-nov-2024.Was there any damage noticed on catheter valve? - not known was the valve cracked or broken? - not known was there leakage noticed at the catheter valve? - not known was the clamp open when valve disconnected from the catheter? - no if yes, was the clamp open when valve disconnected from the catheter? - no where is the catheter located? abdomen or chest - abdomen is there a photo or sample available showing the reported issue? - see in the first mail from us - sample available date of event - date received: 2024-10-22.
Additional Manufacturer Narrative
H10: manufacturing review: one valve sample was provided to our quality team for investigation.Through visual inspection, we can confirm that the internal valves were potentially pulled/moved out of alignment.However, we are unable to determine when or how this occurred.The internal access openings are present.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001534421 was performed and no recorded quality problems or rejections related to this incident were found.Product undergoes inspections during manufacturing, no issues related to the reported incident were identified, all procedural and functional requirements for product release have been met.Although we can confirm a failure with internal valve placement, we are unable to determine when the failure occurred.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: 20747876
• Report Number: 1625685-2024-00126
• Device Sequence Number: 12834035
• Product Code: PNG
• UDI-Device Identifier: 10885403500831
• UDI-Public: (01)10885403500831(10)000134421
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160437
• 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): 02/07/2025

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: Other
• Device Catalogue Number: 50-9050A
• Device Lot Number: 0001534421
• 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: 02/07/2025
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2023
• 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