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

Catalog Number	50-7000B
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
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: a180104 patient problem code: f26.
Event or Problem Description
It was reported by customer that rusty scissors.Rcc received a complaint via phone.Pir attached product complaint (b)(4) ref: 50-7000b lot: 0001539010 issue: customer reported rusty scissors.Pt harm: no in response to your inquiry, please see the below: 1.Can you please provide an exact date of event? march 26, 2024 2.How are the products stored until use? stored in the customer's office.3.When was this defect observed? during or before use? before use, during prep for the procedure.
Event or Problem Description
It was reported by customer that rusty scissors.Verbatim rcc received a complaint via phone.Pir attached ref: 50-7000b; lot: 0001539010.Issue: customer reported rusty scissors.Pt harm: no.Sample: yes.Customer is requesting replacement of four items.Customer response on april 11, 2024 in response to your inquiry, please see the below: 1.Can you please provide an exact date of event? march 26, 2024.2.How are the products stored until use? stored in the customer's office.3.When was this defect observed? during or before use? before use, during prep for the procedure.4.Sample available is mentioned as yes, are you able to provide the address of the facility for us to ship the return label? yes, sample available.Customer advised they have 1ea that was affected and an additional 3ea from the same lot number.Customer is requesting to return/credit all 4 ea as they are wary to use product from the same lot number as the affected item.
Additional Manufacturer Narrative
Pr (b)(4) follow-up emdr for device evaluation: four samples of lot 0001539010 were provided to our quality team for investigation.One tray with damaged lidocaine vials and discoloration/rust was received.Visual discoloration, likely rust on forceps was confirmed.Broken lidocaine vial, potentially causing the discoloration, likely rust.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001539010 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 sterilization record was reviewed, and no issues with product damage was reported.An email was sent to distribution to notify the team of damage observed during the sample review.Based on the quality team's investigation, it was identified that the potential cause of the discolored/rusted forceps is the liquid from the broken lidocaine vials.The root cause of the lidocaine vial damage is unknown.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: 19119277
• Report Number: 1625685-2024-00036
• Device Sequence Number: 8359846
• Product Code: DWM
• UDI-Device Identifier: 10885403075971
• UDI-Public: (01)10885403075971
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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): 08/12/2024

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 Expiration Date: 08/31/2025
• Device Catalogue Number: 50-7000B
• Device Lot Number: 0001539010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2023
• 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