MAUDE Adverse Event Report: CAREFUSION, INC PLEURX DRAINAGE KIT 1000ML; PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING

Catalog Number	50-7510
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a0501.Patient problem code: f26 h3 other text : see manufacture narration.
Event or Problem Description
It was reported: customer received kit with defective issue; no pt harm.Event description states: could not screw on tube defect.Additional info from customer: could you please provide a further description of the issue? customer state the cap that you snap on after you attached the bottle was not working.Was the drainage line disconnected from the bottle at any point during the drain or was it noticed prior to drainage? noticed this issue after she was finished draining.If it is before use and did, they attempt to reconnect it? need to verify the line was disconnected prior to use and the bottle was discarded immediately, bottle was not used.Bottle was used and only was able to pull a little then discarded the bottle.Was the clamp properly closed until after the plunger was pressed yes.Where is the catheter located? abdomen or chest ?abdomen.Is there a photo or sample available showing the reported issue? if yes, please provide mailing address and email address.No.What was the impact to the patient? no.What is the number of occurrence? no.What is the event date? no.Are you able to identify the batch number? no.
Event or Problem Description
Event description states: could not screw on tube defect additional info from customer: - could you please provide a further description of the issue? customer state the cap that you snap on after you attached the bottle was not working.- was the drainage line disconnected from the bottle at any point during the drain or was it noticed prior to drainage? noticed this issue after she was finished draining.- if it is before use and did, they attempt to reconnect it? - need to verify the line was disconnected prior to use and the bottle was discarded immediately, bottle was not used.Bottle was used and only was able to pull a little then discarded the bottle.- was the clamp properly closed until after the plunger was pressed yes - where is the catheter located? abdomen or chest ?abdomen -is there a photo or sample available showing the reported issue? if yes, please provide mailing address and email address.No - what was the impact to the patient? no - what is the number of occurrence? no - what is the event date? no -are you able to identify the batch number? no.
Additional 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, and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.We would be very interested in examining product that does not meet your expectations and our quality standards.A photo of the defect could assist our quality team in their investigation.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis of the affected device.Examination of the product involved may provide clarification as to the cause for the reported failure.We regret any inconveniences this incident may have caused you and your facility.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.H3 other text : see manufacture narration.

• Brand Name: PLEURX DRAINAGE KIT 1000ML
• Common Device Name: PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING
• Manufacturer (Section D): CAREFUSION, INC; zona franca las americas; santo domingo
• Manufacturer (Section G): CAREFUSION, INC; zona franca las americas; santo domingo
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 17775355
• Report Number: 9680904-2023-00033
• Device Sequence Number: 20396350
• Product Code: PNG
• UDI-Device Identifier: 10885403090707
• UDI-Public: (01)10885403090707
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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): 10/06/2023

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: Lay User/Patient
• Device Catalogue Number: 50-7510
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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