MAUDE Adverse Event Report: CAREFUSION, INC THORACENTESIS/PARACENTESIS TRAY; THORACENTESIS TRAY

Catalog Number	TPT1000
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2023
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: a0201 patient problem code: f24.
Event or Problem Description
It was reported by consumer that licaine did not numb the patient.Verbatim: rcc received a complaint via email.Email(s) attached.Description: licaine did not numb the patient lot: 001520449 lidocaine lot: gt7587 catalog number: tpt1000.
Event or Problem Description
It was reported by consumer that licaine did not numb the patient.Verbatim: rcc received a complaint via email.Email(s) attached.Description: licaine did not numb the patient lot: 001526865.Lidocaine lot: gt7587.Lot: 001520449.Lidocaine lot: gt7587.Catalog number: tpt1000.Please reach out and request to verify the following: any sample or photo available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? no, the only thing i have are the outer package of the tray itself.Can you provide a exact date of event? 12/27.Did the event directly, or indirectly involve a patient or user? yes.Response received: was the lidocaine not effective? it was not effective.What was the impact to the patient? the patient could feel still during the procedure, a different lidocaine was used.Is there a photo or sample available showing the reported issue? if yes, please provide mailing address and email address: no.Was there any medical intervention required including diagnostics, procedures, and treatment delay? used a different lidocaine after the patients remarks.How was the issue resolved? used a different lidocaine after the patients remarks.
Additional Manufacturer Narrative
Pr (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 0001520449 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, no deviations or damage was reported.Retains were reviewed, and all samples met specifications per the local standard.The supplier was alerted as part of quality notification in an effort to raise awareness and to inquire about any additional testing that may have been performed.The vendor returned with a response that included test results per the certificate of compliance, no issues were found.Based on the available information, we are unable to confirm a supplier or manufacturing failure, as no issues were identified reviewing the incoming inspection records that include the certificate of conformance from the supplier, and no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported failure.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: THORACENTESIS/PARACENTESIS TRAY
• Common Device Name: THORACENTESIS TRAY
• 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: 18518166
• Report Number: 1625685-2024-00005
• Device Sequence Number: 20520892
• Product Code: PXI
• UDI-Device Identifier: 10885403108488
• UDI-Public: (01)10885403108488
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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): 03/05/2024

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: TPT1000
• Device Lot Number: 0001520449
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2023
• Supplement Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 03/05/2024
• 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
• Patient Sex: Unknown