MAUDE Adverse Event Report: CAREFUSION, INC PLEURX PLEURALCATHETER MINI KIT; APPARATUS, SUCTION, PATIENT CARE

Catalog Number 50-7050

Device Problem Fluid/Blood Leak (1250)

Patient Problem Discomfort (2330)

Event Date 02/12/2024

Event Type  Injury  

Manufacturer Narrative

Pr 9697044 initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a050401.Patient problem code: f1903.

Event Description

After deployment its leaking.Detailed course of treatment planning to change the catheter.21-feb-2024- received an email response from complainant for information requested.1.Could you please provide a further description of the issue " after deployment its leaking"---after deployment patient gone to home and raised a concern that its leaking and consulted to doctor for further checkup.2.Where did the leakage occurred? is this at the insertion site to body?--- yes.3.Is this at the access tip and the catheters valve? specify the component where leak occurred---no.4.Was there damage noted on the access tip or patient's valve- no.5.Was the catheter damaged/ broken/ disconnected?---unknown.6.Where is the catheter located?--- pleural cavity.7.What was the impact to the patient? --- discomfort due to leakage.8.Was there infection noticed at the insertion site due to leakage?---no.9.Was there any medical intervention required including diagnostics, procedures, and treatment delay?---they removed the catheter.10.Could you please provide lot number associated with reported issue?--- 0001523691 11.How long has the catheter been in place?---4 days.12.Is there a photo or sample available showing the reported issue for the evaluation?---no.13.How was the issue resolved?---removed the catheter.14.As per sales force form - detailed course of treatment - planning to change the catheter.Was there a catheter replacement?---not yet (as there were very less fluid in the cavity).15.Exposure to blood/bodily fluid - yes - was the blood/ body fluid was exposed to face/eyes?---no.

• Brand Name: PLEURX PLEURALCATHETER MINI KIT
• Type of Device: APPARATUS, SUCTION, PATIENT CARE
• 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: 18812700
• MDR Text Key: 336600314
• Report Number: 1625685-2024-00023
• Device Sequence Number: 1
• Product Code: DWM
• UDI-Device Identifier: 10885403075988
• UDI-Public: (01)10885403075988
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K160450
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 50-7050
• Device Lot Number: 0001523691
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other