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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr (b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: (b)(4).Patient problem code:(b)(4).
Event or Problem Description
It was reported that device had defective/damaged piece and unable to drain.Verbatim: inside the kit there is a connection tubing, there is a ¿christmas¿ tree connector and it was completed block.It was just a piece of solid plastic.It would not drain.There was no patient impact but she did state the patient had to stay in the operating room for an extra 30 minutes.(b)(6) 2022: what was the procedure that was being performed: pleurx catheter placement.Was there a need to repeat the procedure? no, but it was close to that.How was the issue resolved? we disconnected the pleurx from the connection tubing and realized that the christmas tree connector was not patent.We exchanged a new one and it was functioning afterwards.What is the ref/material number of the product? 50-7000b is the catalog number.What is the lot number of the product? do not know.Is there a photo or sample available showing the reported issue for the evaluation? i have attached the photo.Were they able to complete the diagnosis correctly? the procedure was completed, but was about 40 minutes extra of procedure time trying to troubleshoot.
Event or Problem Description
It was reported that device had defective/damaged piece and unable to drain.Verbatim: inside the kit there is a connection tubing, there is a ¿christmas¿ tree connector and it was completed block.It was just a piece of solid plastic.It would not drain.There was no patient impact but she did state the patient had to stay in the operating room for an extra 30 minutes.21nov2022: sorry for the delay in getting back to you.Here is the information: what was the procedure that was being performed: pleurx catheter placement was there a need to repeat the procedure? no, but it was close to that.How was the issue resolved? we disconnected the pleurx from the connection tubing and realized that the christmas tree connector was not patent.We exchanged a new one and it was functioning afterwards.What is the ref/material number of the product? 50-7000b is the catalog number.What is the lot number of the product? do not know.Is there a photo or sample available showing the reported issue for the evaluation? i have attached the photo.Were they able to complete the diagnosis correctly? the procedure was completed, but was about 40 minutes extra of procedure time trying to troubleshoot.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: two photos were provided to our quality team for investigation.Upon visual inspection of the photos, it was observed that there was an obstruction towards the end of the adapter therefore, the reported failure mode was confirmed.A device history record could not be evaluated as the lot number is unknown.Based on the available information we are not able to identify a root cause at this time.Manufacturing personnel have been notified of this incident and awareness training was provided.A quality notification has been sent to the supplier.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 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: 15883649
• Report Number: 1625685-2022-00100
• Device Sequence Number: 5298394
• Product Code: DWM
• UDI-Device Identifier: 10885403075971
• UDI-Public: (01)10885403075971
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 02/09/2023

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: Health Professional
• Device Model Number: 50-7000B
• Device Catalogue Number: 50-7000B
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/15/2022
• Supplement Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 02/10/2023
• 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