MAUDE Adverse Event Report: CAREFUSION, INC PERITX PERITONEAL CATHETER MINI KIT; PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING

Catalog Number 50-9050A

Device Problem Device Handling Problem (3265)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2023

Event Type  malfunction  

Event Description

Injury (patient / other): no.Product possible.Involved in injury: no.Product available for inquiry: no.Complaint: perforated valve and a broken insertion pin.According to her, this was definitely not a material defect, but very rough handling.Valve change product: item no.: 50-9050a/v001 - peritx aszites¿ horns.Additional affected article no.: 50-9050a/v001 - peritx aszites¿ horns.Additional affected lot no.: 0001500128.Additional udi no.: not specified.Affected component article no.: affected component lot no.: additional informations: description of issue (what / why): perforated valve and a broken insertion pin.According to her, this was definitely not a material defect, but very rough handling.Valve change.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: change valve.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: change valve.Exposure to blood / bodily fluid: no.Course of treatment changed due to event: no.Time catheter in place: 11.10.2023.Connected device (pleurx/peritx/brand) 50-9050a.Procedure performed by: physician.Procedure performed at: hospital.Replacement requested: no.Credit requested: yes.Additional information: information about the error pattern: fault location: valve.Error type: cropped.Response received: 28/nov/2023.1.Could you please provide a further description of the issue (perforated valve and a broken insertion pin)? - perforated valve.2.Was the access tip of the drainage line broken off in the valve of the catheter? - not known.3.Was the valve cracked or broken? not known.4.If yes, what was the cause of the damaged valve.Not known.5.Was the cause of the issue being due to the rough handling (user error) - yes 6.Was there any medical intervention required including diagnostics, procedures, and treatment delay? no.7.What was the impact to the patient? valve change.A.Where was the catheter located? abdomen or chest abdomen.8.We would like to ask you to confirm if any samples are available.For.Investigation.If yes, could you please specify if the samples are: sample is not available.A.Unused (before use).B.Used (during or after use).C.Important: if used, please confirm if the samples have been used or are contaminated with blood or cytotoxic medication.9.Please also provide us with the full pickup address, contact name and number, department name, floor number, and any additional details such as (pick up at reception, goods in yard, etc.) and we will schedule sample pick-up request for you using tnt carrier.10.If it is not possible to return the physical sample, can you provide detailed photographs of the affected product? no, the complained valve was directly thrown away.11.How long has the catheter been in place? 2023-10-11.

Manufacturer Narrative

Pr (b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a2301.Patient problem code: f26.

Event Description

Injury (patient / other): no.Product possible.Involved in injury: no.Product available for inquiry: no.Complaint: perforated valve and a broken insertion pin.According to her, this was definitely not a material defect, but very rough handling.Valve change.Product: item no.: 50-9050a/v001 - peritx aszites¿ horns.Additional affected article no.: 50-9050a/v001 - peritx aszites¿ horns.Additional affected lot no.: 0001500128.Additional udi no.: not specified.Affected component article no.: / -.Additional informations: description of issue (what / why): perforated valve and a broken insertion pin.According to her, this was definitely not a material defect, but very rough handling.Valve change 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: change valve.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: change valve.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: physician.Procedure performed at: hospital.Replacement requested: no.Credit requested: yes.Additional information: information about the error pattern: fault location: valve.Error type: cropped.Response received: 28/nov/2023.1.Could you please provide a further description of the issue (perforated valve and a broken insertion pin)? - perforated valve.2.Was the access tip of the drainage line broken off in the valve of the catheter? - not known.3.Was the valve cracked or broken? - not known.4.If yes, what was the cause of the damaged valve.- not known.5.Was the cause of the issue being due to the rough handling (user error) - yes.6.Was there any medical intervention required including diagnostics, procedures, and treatment delay? - no.7.What was the impact to the patient? - valve change.A.Where was the catheter located? abdomen or chest - abdomen.8.- we would like to ask you to confirm if any samples are available for investigation.If yes, could you please specify if the samples are: - sample is not available.A.Unused (before use).B.Used (during or after use).C.Important: if used, please confirm if the samples have been used or are contaminated with blood or cytotoxic medication.9.Please also provide us with the full pickup address, contact name and number, department name, floor number, and any additional details such as (pick up at reception, goods in yard, etc.) and we will schedule sample pick-up request for you using tnt carrier.10.If it is not possible to return the physical sample, can you provide detailed photographs of the affected product? - no, the complained valve was directly thrown away.11.How long has the catheter been in place? ¿ (b)(6) 2023.

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.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001500128 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.Based on the quality team's investigation, it was identified that the probable root cause is traced to user rough handling but not related to not a material defect.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.

• Brand Name: PERITX PERITONEAL CATHETER MINI KIT
• Type of Device: 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: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 18267899
• MDR Text Key: 330039250
• Report Number: 1625685-2023-00121
• Device Sequence Number: 1
• Product Code: PNG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K201155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 50-9050A
• Device Lot Number: 0001500128
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other