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

Catalog Number	50-9050
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Catheter not draining.As you stated by dr (b)(6) patient has a pleurx peritoneal drain insitu.Seemed to have blockage last week which you were able to clear used the pleurx access kit.Now catheter not draining.Imaging shows catheter in correct place and not loculations.Have placed these catheters previously and had no issue.Will either just remove or replace catheter depending of attending physicians decision.
Additional Manufacturer Narrative
Pr (b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).
Additional Manufacturer Narrative
(b)(4).Follow-up emdr for device evaluation: one sample was provided to our quality team for investigation.Through visual inspection of the section of tubing with the valve, the sample tubing was pulled apart with hemostats and the valve was pulled apart was examined.Both the short section of tubing and the valve had foreign matter.When the tubing and valve pieces were tapped against the counter, several small pieces fell loose.This foreign matter had the appearance of dried tissue when examined under magnification; therefore, the reported failure could be verified.A device history review could not be completed as no batch number was provided.Based on the available information we are not able to identify a root cause at this time.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.H3 other text: see manufacturer here.
Event or Problem Description
Catheter not draining as you stated by dr (b)(6): patient has a pleurx peritoneal drain insitu; seemed to have blockage last week which you were able to clear used the pleurx access kit; now catheter not draining; imaging shows catheter in correct place and not loculations; have placed these catheters previously and had no issue; will either just remove or replace catheter depending of attending physicians decision please make contact to advise if he has removed or replaced catheter and if removed arrange for pick up to have it investigated answer for internal follow up is received on 24 dec 2021-vitya.K was there tissue causing the line to be occluded? couldn't see contrast at distal end so assumed it was tissue but when removed they couldn't visible see anything.Was there catheter occluded or the drainage line? catheter.What was done to resolve the issue? catheter replaced and running well.Did they connect a new bottle and successfully complete the drainage? no.When was the catheter placed and where is it located? abdominal.Is there a photo or sample available showing the reported issue for the evaluation? sample ready for pick up - what was the impact to the patient? delay in drainage and having to have a new drain inserted.

• Brand Name: PLEURX 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: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 13059945
• Report Number: 1625685-2021-00102
• Device Sequence Number: 1608578
• Product Code: PNG
• UDI-Device Identifier: 50885403075962
• UDI-Public: (01)50885403075962
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: 50-9050
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2021
• Supplement Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 03/24/2022
• 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