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

Model Number	50-7000B
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	09/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).
Event or Problem Description
It was reported by the customer that the piece from the product was not patent.Verbatim: an incident that happened around 5 pm, after surgery regarding a patient.The fellow came to the surgery front desk and informed of an incident.Patient had a tension pneumo following his video assisted thoracotomy with a pleurax placement.A white connector piece from the kit was not patent.He was trouble shooting the system at the patient's bedside of why the catheter was not working properly.When he disassemble the setup, he noticed the piece from the kit was not patent.This piece was immediately removed and changed and then the catheter was working properly.The fellow brought the connector back to the operating room for the surgical services to follow up.I called sicu to check on the patient he was stable and doing well.The lot number of the inserted catheter is 0001471891 we had 2 in the surgical unit that were pulled, and materials management was notified of the lot number to pull and retain all units to swap out for different kits.Fda safety report id# (b)(4).
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 0001471891 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.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.
Event or Problem Description
It was reported by the customer that the piece from the product was not patent.Verbatim: an incident that happened around 5 pm, after surgery regarding a patient.The fellow came to the surgery front desk and informed of an incident.Patient had a tension pneumo following his video assisted thoracotomy with a pleurax placement.A white connector piece from the kit was not patent.He was trouble shooting the system at the patient's bedside of why the catheter was not working properly.When he disassemble the setup, he noticed the piece from the kit was not patent.This piece was immediately removed and changed and then the catheter was working properly.The fellow brought the connector back to the operating room for the surgical services to follow up.I called sicu to check on the patient he was stable and doing well.The lot number of the inserted catheter is 0001471891 we had 2 in the surgical unit that were pulled, and materials management was notified of the lot number to pull and retain all units to swap out for different kits.Fda safety report id# (b)(4).

• Brand Name: PLEURX PLEURAL CATHETER 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: 15456230
• Report Number: 1625685-2022-00086
• Device Sequence Number: 20557028
• Product Code: DWM
• UDI-Device Identifier: 10885403075971
• UDI-Public: (01)10885403075971
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K160450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2022

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: 04/30/2023
• Device Model Number: 50-7000B
• Device Catalogue Number: 50-7000B
• Device Lot Number: 0001471891
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/02/2022
• Supplement Date Received by Manufacturer: 12/21/2022
• Initial Report FDA Received Date: 09/20/2022
• Supplement Report FDA Received Date: 12/21/2022
• 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