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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Sepsis (2067); Obstruction/Occlusion (2422)

Event Date 02/11/2021

Event Type  malfunction  

Manufacturer Narrative

A follow up emdr will be submitted if additional information becomes available.

Event Description

Doctor has deployed peretonial kit to a male patient 45 days back.Now the patient came to doctor and dr found that membranous formation has happened inside the cavity around catheter which has formed pockets and hence fluid drainage has stopped.

Manufacturer Narrative

No complaint sample or photo was provided for evaluation.Consequently, the investigation was not able to confirm the reported failure mode.Dhr review did not identify any manufacturing issues which might have contributed to the failure mode.Additionally, since no samples and no photos were received for evaluation, the investigation was unable to confirm the reported failure mode nor identify any potential issues during manufacture.A probable root cause could not be determined at this time.The complaint will be entered into the complaint management system and will be tracked & trended for future occurrences.

Event Description

Doctor has deployed peretonial kit to a male patient 45 days back, now the patient came to doctor and dr found that membranous formation has happened inside the cavity around catheter which has formed pockets and hence fluid drainage has stopped.

• 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
• MDR Report Key: 11369442
• MDR Text Key: 233245863
• Report Number: 1625685-2021-00018
• Device Sequence Number: 1
• Product Code: PNG
• Combination Product (y/n): N
• PMA/PMN Number: K160437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 50-9050
• Device Lot Number: 0001160341
• Date Manufacturer Received: 06/25/2021
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention