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

Catalog Number 50-9050

Device Problem Leak/Splash (1354)

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

Event Date 08/12/2022

Event Type  malfunction  

Manufacturer Narrative

Pr (b)(6) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: (b)(4).

Event Description

Valve was leaking.Patient received free replacements.Valve was changed.Safety clamp was used.Manipulation.Was there any damage noticed on catheter valve? unknown.Was the valve cracked or broken? manipulated.Where is the catheter located? abdomen or chest / abdomen.Is there a photo or sample available showing the reported issue? a sample is available.Does replacing the valve fixed the problem? yes.Did the patient require additional diagnostics other than the valve replacement to be able to drain.Unknown.How long has the catheter been in place? (b)(6) 2022.What was the impact to the patient? no impact.

Manufacturer Narrative

(b)(4).Follow-up emdr for device evaluation: one sample was provided to our quality team for investigation.Through visual inspection, it was observed that the disk and bi-directional valves were missing from the access valve assembly.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001343926 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 determined that the probable root cause of the leakage was a result of missing components inside of the valve.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.

Event Description

Valve was leaking.Patient received free replacements.Valve was changed.Safety clamp was used.Manipulation.Was there any damage noticed on catheter valve? unknown.Was the valve cracked or broken? manipulated.Where is the catheter located? abdomen or chest : abdomen.Is there a photo or sample available showing the reported issue? a sample is available does replacing the valve fixed the problem? yes.Did the patient require additional diagnostics other than the valve replacement to be able to drain.Unknown.How long has the catheter been in place : (b)(6) 2022.What was the impact to the patient? no impact.

• Brand Name: PLEURX 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: 15327165
• MDR Text Key: 305508557
• Report Number: 9680904-2022-00032
• Device Sequence Number: 1
• Product Code: PNG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K160437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 50-9050
• Device Lot Number: 0001343926
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 08/31/2022
• Supplement Dates Manufacturer Received: 12/20/2022
• Supplement Dates FDA Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other