MAUDE Adverse Event Report: CAREFUSION, INC PLEURX PLEURAL CATHETER AND STARTER KIT; APPARATUS, SUCTION, PATIENT CARE

Catalog Number	50-7700
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by consumer that patient was having a procedure to remove the pleurx catheter.The catheter was stuck in the patient and could not be removed.Thoracic surgery had to be called in to intervene and get the catheter out of the patient.Verbatim: patient was having a procedure to remove the pleurx catheter.The catheter was stuck in the patient and could not be removed.Thoracic surgery had to be called in to intervene and get the catheter out of the patient.50-7000b, lot 0001520433.Describe patient / hcp / user impact : thoracic surgeon had to be called in to procedure to intervene.
Additional Manufacturer Narrative
(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: (b)(6).Patient problem code: f1903.
Event or Problem Description
It was reported by consumer that patient was having a procedure to remove the pleurx catheter.The catheter was stuck in the patient and could not be removed.Thoracic surgery had to be called in to intervene and get the catheter out of the patient.Verbatim: rcc received a complaint via email.Email(s) attached.Patient was having a procedure to remove the pleurx catheter.The catheter was stuck in the patient and could not be removed.Thoracic surgery had to be called in to intervene and get the catheter out of the patient.50-7000b, lot 0001520433.Describe patient / hcp / user impact : thoracic surgeon had to be called in to procedure to intervene.
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.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001520433 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.The tensile and elongation testing results performed by the supplier were passing, no issues were identified.The method of removal per the instructions for use is the following."5.Using forceps, dissect around the cuff to free it from the ingrowth.Ensure that the cuff is completely free within the tunnel.6.Grasp the catheter in one hand and pull with a firm, constant pressure." 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.

• Brand Name: PLEURX PLEURAL CATHETER AND STARTER KIT
• Common Device Name: 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: 18669214
• Report Number: 1625685-2024-00014
• Device Sequence Number: 8240328
• Product Code: DWM
• UDI-Device Identifier: 10885403231520
• UDI-Public: (01)10885403231520
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K160450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Catalogue Number: 50-7700
• Device Lot Number: 0001520433
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2024
• Supplement Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2023
• 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